Current Openings
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- Qualify and develop relationships and train surgeons, who specialize in treating complex spinal pathologies including deformity, trauma, and tumor on K2M systems.
- Develop & train sales agency associates & principals in education, preparation, and implementation of deformity & complex spinal procedures.
- Assist in the training of key hospital staff on the use of K2M products in deformity & complex spinal procedures.
- Work with medical education department in selection and implementation of course sites and venues for training courses.
- Provide user feed back and development ideas to VP of Complex Spine Unit. When requested attend product development input & output meetings at K2M.
- Develop key relationships with Deformity Silo members and BSA located in the designated area.
- Attend and assist with industry & professional society meetings.
- Work closely with AVP's with Agency development & feedback & sales plan/strategy implementation.
- Executes activities as directed by Medical Education program including national and regional HCIR and/or surgeon courses and workshops.
- Tracks registration, attendance, and proficiency for HCIRs training course attendees and provides regular reports to sales management teams
- Assists in creating, revising, branding, and maintaining updated product training presentations and handouts in collaboration with product management teams
- Demonstrates proficiency in project management including contracting with vendors, negotiating pricing, tracking actual program expenditures, and data analysis for return on investment and budget forecasting
- Responsible for managing K2M.com’s eLearning site on extranet including: editing, and developing website content, working closely with vendors and/or MarCom Mgr to ensure updated calendar, content, layout, navigation, and consistency of branded contents.
- Plans and conducts e-mail campaigns and course registrations
- Manages BioSkills lab on site and supports management of BioSkills labs offsite.
- Provides best practices and universal precautions training to other departments in support of management of BioSkills lab.
- Conducts in-depth, internet research and analysis of industry educational programs and meetings as well as conducts literature searches for peer reviewed publications.
- Travels to K2M national and regional educational events and to major spine society meetings.
- Performs all other related duties as required by the Medical Education Group
- Proficient in use of software and technology to develop and to present educational programs.
- Ability to create, compose, and edit written materials.
- Ability to investigate and analyze information and to draw conclusions.
- Ability to gather and analyze statistical data and generate reports including budget projections and progress reports.
- Ability to make administrative/procedural decisions and judgments.
- Knowledge of conference facilities, technology, and meeting equipment including Audience Response System..
- Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
- Ability to develop, plan, and implement short- and long-range goals.
- Ability to negotiate and manage contractual arrangements.
- Knowledge of finance, accounting, budgeting, and cost control procedures.
- Skill in organizing resources and establishing priorities.
- Knowledge and understanding of meeting and event planning principles, requirements, procedures, and available resources.
- Show initiative, resourcefulness, creative thinking, and adaptability.
- Ability to perform complex tasks and to prioritize multiple projects.
- Participates in overall product strategy, research and development requirements, development, and manufacturing coordination for new and emerging products.
- Coordinates technical product development, estimates of potential profits, and release to production specific to the family of spinal products and procedures.
- Establishes operational and project objectives and assignments and delegates assignments to project team. Directs and coordinates the activities of project team personnel (engineering, manufacturing, procurement, marketing and quality) to ensure projects progress on schedule and within prescribed budget.
- Performs market analysis and product strategy development.
- Conducts surgeon and sales rep product and procedure training.
- Collaborates with a wide variety of functional areas such as sales, engineering, marketing, manufacturing, and operations to develop and provide product definitions responsive to customer needs and market opportunities.
- Produce competitive analysis materials comparing product with its key competitors.
- Establish and maintain relationships with key spine / neuro surgeons.
- Provides technical expertise and training to other departments in support of product development.
- Identifies market potential, establishes pricing and market strategies, estimates potential sales, introduces market, distribution/channel issues, and manages mature product through phase-out.
- Manages the development stage of the product life cycle. Responsible for ensuring that all customer requirements are met including the monitoring of test reports, documentation of instructions, etc.
- Defines promotional activities, publicizing the product through the press, sales force, and alternate distribution channels. Plan and manage trade show activities.
- Staff Development - Working closely with Human Resources, prepares and implements a specific development plan for each direct report, assisting the direct report in developing himself/herself in achieving maximum performance and professional growth. Conducts periodic "performance discussions" to identify areas of strength, opportunities for improvement, jointly s setting short-term business and personal development goals. Provides opportunities for growth which have clear cut objectives with well laid out performance standards.
- Provides direct reports with learning opportunities such as seminars/schools.
- Closely monitors time management of direct reports such that they are able to carry out primary responsibilities without distraction from purpose. Aids the subordinate in understanding and realizing the vision of the position and his or her personal contribution to K2M.
- 5 -10 years experience in medical device Product Management
- Orthopedic/Spine experience a plus
- 3-5 years successful experience managing direct reports.
- 3-5 years experience managing operational expense budgets required
- Familiarity with and proficiency in working with surgeons
- Demonstrated leadership and team building/management skills essential
- Excellent Public speaking and presentation skills are essential
- Computer proficiency in all Microsoft office applications
- Team orientation - Able to build team relationships with other business disciplines (e.g. interfaces continuously with engineering, R and D, manufacturing, procurement, finance, sales and executive personnel)
- Participates in overall product strategy, research and development requirements, development, and manufacturing coordination for new and emerging products.
- Coordinates technical product development, estimates of potential profits, and release to production specific to the family of spinal products and procedures.
- Establishes operational and project objectives and assignments and delegates assignments to project team. Directs and coordinates the activities of project team personnel (engineering, manufacturing, procurement, marketing and quality) to ensure projects progress on schedule and within prescribed budget.
- Collaborates with a wide variety of functional areas such as sales, engineering, marketing, manufacturing, and operations to develop and provide product definitions responsive to customer needs and market opportunities.
- Identifies market potential, establishes pricing and market strategies, estimates potential sales, introduces market, distribution/channel issues, and manages mature product through phase-out.
- Manages the development stage of the product life cycle. Responsible for ensuring that all customer requirements are met including the monitoring of test reports, documentation of instructions, etc.
- Defines promotional activities, publicizing the product through the press, sales force, and alternate distribution channels. Plan and manage trade show activities.
- Master Receipts Routing & Inventory Transfers
- Proficient in Microsoft Excel
- Proficient in cycle counting and inventory reconciliation
- Transact all parts within K2M inventory
- Maintain the quality production program to ensure conformity of materials and final products to quality and regulatory standards
- Coordinate corrective actions and resolve quality concerns for any product or component.
- Write, review and/or revise all departmental SOPs and work instructions and ensure compliance.
- Participate in establishment of uniform corporate quality procedures
- Write, review, and approve product specifications on purchased products, in-process and finished products.
- Produce written reports of special projects as needed.
- Provide training, supervision and technical guidance to all QC employees.
- Identify relevant quality-related training needs.
- Review and approve outgoing product.
- Coordinate product testing (in-house and outside lab testing) on Competitors’ samples,
- Marketing New Product samples, R&D and Process Engineering pilot samples.
- Perform internal and vendor audits and suppliers.
- Complete various forms and documentation as related to reporting inspection results.
- Communicate both verbally and written with coworkers and management regarding procedures, inspection, requirements and other elements of quality assurance.
- Perform house keeping duties to maintain a clean and safe work environment
- Inform managers of any potential problems
- Interact professionally and diplomatically with managers, co-workers, and suppliers
- Establish work priorities for the QC department.
- Read, understand, and comply with FDA Regulations, ISO requirements, and company standard operating procedures.
- Conduct performance reviews for the QC department.
- Other duties as assigned.
- Ability to read and understand technical drawings, customer specifications, and work
- Ability to follow procedures and maintain quality of precuts at all time
- Must be detail orientated, self-motivated, and able to multi-task
- Experience with ANSI Y14.5 Geometric Tolerances.
- Experience with ANSI / ASQC Z1.4 Sampling Plan.
- Working knowledge of GMP compliance for Class II Medical Devices.
- Hands-on experience with micrometers, calipers, dial and digital indicators, optical comparator, ring gauges, pin gauges, and thread gauges
- Understanding of thread specifications and classifications.
- Basic understanding of machining processes
- Familiar with cGMPs.
- Strong written and verbal communication, math, computer and organizational skills required.
- Good supervisory and training skills required. Ability to continuously train employees
- Answers incoming calls from sales agents and field sales in a timely manner for ordering product and/or resolving issues with professional phone etiquette.
- Develops and monitors programs, work instructions, procedures and policies to ensure transfer order processing with on-time delivery and sales order processing with invoicing to meet consistent customer service and satisfaction. Utilize procedures for process improvement that involve software updates and upgrades.
- Schedules staff to adequately handle call volume, including emergency on call coverage, customer requirements on purchase orders, order acknowledgments, amendments and return authorizations, product experience reports maintaining appropriate files evidencing transactions and requesting additional information from the field as necessary.
- Acts as primary source of information to solve agent related problems including, but not limited to, order entry, delivery dates, change orders, credit/rebill, requests for product literature, promotional items, product returns, customer complaints or service issues. Troubleshoots and resolves non-routine customer complaints with 100% satisfaction in a timely manner and in accordance with company guidelines. Monitors backlog report; keeps agents up-to-date on order status. Quality check orders, schedules loaner set usage and works closely with inventory control manager to resolve loaner issues, contact agents, and assume proper billing of loaner usage and discrepancies.
- Establishes and manages processes to collect data on hospitals, agents, and doctors and maintains JDE database and files relating to same.
- Establishes escalation procedures for customer issues and provides feedback to K2M regarding service failures or customer concerns. Establishes and maintains logs of customer complaints per K2M policy.
- Hires, trains, motivates, leads and evaluates customer service staff. Executes proper product and customer service training. Performs daily coaching to develop employees and ensure superior customer service skills. Develops and implements motivation/reward programs that ensure high performance. Addresses discipline and /or performance problems according to company policy.
- Thoroughly understands and utilizes all proprietary systems, telecommunications systems, reporting tools, desktop applications and office support systems to support business requirements.
- Uses customer knowledge and job expertise to identify and recommend opportunities to enhance customer service, improve departmental processes by streamlining and reduce supply chain expenses.
- Ensures all Customer Service activities are in compliance with Quality System requirements. Understands and communicates importance of Revenue Recognition which reflects adherence to K2M’s Code of Conduct.
- Participates in the development and implementation of department goals and objectives to foot to the company’s goals and objectives.
- Keeps records of customer interactions and transactions, recording details of inquiries, complaints and comments, as well as actions taken. Provides Field Feedback to other departments throughout the organization with a resolution and applying change management as necessary. Records commission deductions electronically forwarding documentation to Accounting meeting the month-end close timeline.
- Establishes departmental metrics and reports.
- Executes and understands K2M’s asset management strategies. Aids field sales to manage consignment and excess inventory. Utilize influence management skills to negotiate with field on inventory levels.
- Evaluates customer satisfaction levels and provides results on a regular basis.
Area Director, Complex Spine Unit
Summary: The Area Director, Complex Spine Unit will be focused upon complex spine and deformity procedures, extensive product knowledge and clinical expertise with all K2M products in this position.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
Education/Experience:
Bachelor’s degree or equivalent; and four to ten years related experience and/or training; or equivalent combination of education and experience. Background in deformity and complex spinal procedures preferred.
Send resumes and salary requirements to: humanresources@k2m.com
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Associate Program Manager, Medical Education
Summary:
Supports the Director Medical Education in implementing and evaluating educational programs of the division. Provides logistical and administrative support for multiple, complex educational programs targeting HealthCare Industry Representatives (HCIR) and surgeons. This person will develop and distribute Med Ed collateral materials including curriculum, event promotional communications, and will often work independently to complete requested projects within a specified time frame
Essential Duties and Responsibilities include the following:
Knowledge, skills, and abilities required:
Send resumes and salary requirements to: humanresources@k2m.com
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CAD Designer
Summary: The CAD Designer will be responsible for supporting research and development efforts. Incumbent will generate solid models with SolidWorks based on input from Senior Engineers.
Essential Duties and Responsibilities include the following.
•Incumbent will generate solid models with SolidWorks based on input from Senior Engineers
•Make production drawings of mechanical devices using proper dimensioning, generate parts lists and maintain documentation control and on occasion, make other layouts utilizing SolidWorks and other solid modeling software.
•The successful applicant will interface with local machine shops from time to time.
Knowledge, skills, and abilities required:
•SolidWorks expertise and proficiency in ANSI Y14.5 standards are desired.
•Must be familiar with metal machining and fabrication processes.
•Experience with GD&T is a plus.
•Should have the ability to solve problems and work independently.
•Other CAD experiences a plus.
Send resumes and salary requirements to: humanresources@k2m.com
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CAD Designer
Summary: The CAD Designer will be responsible for supporting research and development efforts. Incumbent will generate solid models with SolidWorks based on input from Senior Engineers.
Essential Duties and Responsibilities include the following.
•Incumbent will generate solid models with SolidWorks based on input from Senior Engineers
•Make production drawings of mechanical devices using proper dimensioning, generate parts lists and maintain documentation control and on occasion, make other layouts utilizing SolidWorks and other solid modeling software.
•The successful applicant will interface with local machine shops from time to time.
Knowledge, skills, and abilities required:
•SolidWorks expertise and proficiency in ANSI Y14.5 standards are desired.
•Must be familiar with metal machining and fabrication processes.
•Experience with GD&T is a plus.
•Should have the ability to solve problems and work independently.
•Other CAD experiences a plus.
Education/Experience:
AA degree in CAD, Engineering, or related discipline.
Send resumes and salary requirements to: humanresources@k2m.com
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Group Product Manager
Summary:
Manages multiple product lines and/or Product Managers/Associate Product Managers assigned to Product Group. Plans, organizes, and controls assigned product lines from conceptual stages through product life cycles to optimize profit and meet marketing, financial, and corporate growth objectives by performing the following duties. Collaborates with Senior Engineering Development and Executive leaders to create and direct strategic growth plans for assigned product areas.
Essential Duties and Responsibilities include the following:
Knowledge, skills, and abilities required:
Education/Experience:
BA or BS required; MBA preferred. Marketing concentration a plus.
Send resumes and salary requirements to: humanresources@k2m.com
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Manager, Regulatory Compliance
Summary:
The purpose of this position is to provide leadership for the management of a regulatory compliance program that ensures compliance with the federal Food, Drug, & Cosmetic Act (FDCA) and all applicable FDA regulations, and other applicable regulatory bodies and standards, with respect to the marketing and promotion of K2M products.
Essential Duties and Responsibilities:
•Responsible for day-to-day compliance by K2M with the federal Food, Drug, & Cosmetic Act (FDCA) and all applicable FDA regulations regarding marketing and promotion of K2M products.
•Review all K2M marketing and promotional materials (web, video, print, etc.), including any press releases and all product labels, to ensure the proper marketing and promotion of K2M products
•Review for regulatory compliance any presentations given by or on behalf of K2M
•Manage written procedures and policies to ensure the proper marketing and promotion of K2M products
•Provide and oversee training for the K2M sales and marketing team, and other departments as necessary, regarding the proper promotion and marketing of K2M products
•Review and know all of K2M’s regulatory approvals and the approved uses for all K2M products
•Stay current on policy and regulatory updates and changes from the FDA and other applicable governmental bodies, including staying current on guidance documents and compliance actions
•Attend various K2M trade shows, marketing events, and educational events to ensure the proper marketing and promotion of K2M products
Knowledge, Skills, and Abilities required:
•Minimum 5 years experience within a medical device manufacturing environment with direct regulatory compliance experience
•Minimum 2 years managerial experience overseeing aspects of a regulatory compliance program
•Strong decision making skills
•Ability to work independently, plan, and prioritize
•Experience with the FDCA and the FDA Code of Federal Regulations
•Experience with FDA Class I/II/III devices
Education/Experience:
•Bachelor’s degree in technical or science-related field
•Experience with regulations affecting Class I/II/III medical devices, and managing programs for advertising and promotion compliance.
•Regulatory Affairs Certification (preferred)
Send resumes and salary requirements to: humanresources@k2m.com
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Product Manager
Summary: Plans, organizes, and controls an assigned product line from conceptual stages through product life cycles to optimize profit and meet marketing, financial, and corporate growth objectives by performing the following duties.
Essential Duties and Responsibilities include the following:
Education/Experience: B.A. or B.S.; MBA preferred, Marketing concentration a plus, 5 -10 years sales and/or Product Management experience in orthopedics, Spine experience a plus, A combination of both medical device sales and marketing/product management experience essential, Excellent Public speaking and presentation skills are essential, Computer proficiency in all Microsoft office applications.
Send resumes and salary requirements to: humanresources@k2m.com
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Production Technician
Summary: Under direct supervision, cleans, packages, labels, assembles, and kits spinal implants and related instrumentation.
Essential Duties and Responsibilities:
Performs any combination of following tasks to assemble and package spinal implants and related products:
Knowledge, Skills, and Abilities required:
Strong customer service, interpersonal and communication skills are essential. The ideal candidate will have the ability to demonstrate a good understanding of company products, ability to be organized, detailed, process and goal oriented, a self-starter and able to work independently, but also as a team player is necessary.
Education/Experience:
Must possess a high school diploma; and 1 to 3 years related experience and/or training; or equivalent combination of education and experience.
Send resumes and salary requirements to: humanresources@k2m.com
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Quality Control Supervisor
Summary:
Supervise and train QC personnel, direct the flow of product in quality inspection area. Establish and enforce procedures and policies to ensure completion of appropriate testing and documentation according to company policy, cGMPs, and regulatory requirements. Administer in-process and finished products through communication with Marketing, Engineering, QA, Purchasing, Production and Regulatory Affairs.
Essential Duties and Responsibilities include the following:
Knowledge, skills, and abilities required:
Education/Experience:
High school Diploma or GED; some college or technical training preferred. Minimum of: 5 years experience of quality control experience with at least one year in a lead role..
Send resumes and salary requirements to: humanresources@k2m.com
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Sales Support Manager
Summary: This position is responsible for ensuring that customer orders, returns and credits, complaints, requests, etc are resolved in a timely, accurate and cost effective manner upon the first request. The individual will provide metrics for measuring the customer product transactions in an efficient, analytical manner while maintaining a high level of relationship management, quality communications and interaction. Must be detail oriented with a strong work ethic focused on providing a positive customer experience. This position is responsible for accurate product order entry and completing sales order process within K2M’s guidelines and Quality policy.
Essential Job Duties and Responsibilities include the following. Other duties may be assigned.
Knowledge of principles and processed for providing customer service. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction. Excellent listening and communication skills are required along with a positive morale/teamwork building skills and the ability to handle a variety of activities simultaneously. Attention to detail is paramount to ensure accurate processing of product requests and shipping information. Superior time management skills and the ability to manage multiple functions and adhere to daily deadlines. Ability to demonstrate professional, friendly phone skills while maintaining composure in stressful situations. Education/Experience: Bachelor’s degree from a four-year college or university; a minimum of five years experience in the medical device industry; and a minimum of 3 years supervisory experience. International experience a plus.
Knowledge, Skills, and Abilities required:
Send resumes and salary requirements to: humanresources@k2m.com
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