Project Manager

The mission of the Project Manager is to coordinate all internal activities in support of the release of new products to production. PM must maintain timelines, action items lists, and all necessary documentation for design control per FDA GMP's section 820 and ISO 9000. PM is the focal point for communicating project status to management and for communication and coordination of all project activities. To accomplish this mission, the PM must work closely with marketing, engineering, and operational departments to keep critical projects on timeline. Knowledge of product development in a medical device design environment, leadership skills, and the ability to work with others are essential.

Duties and Responsibilities:

• Responsibility for all new product introduction project related activities which include applying project / program management methodology in efforts to:  develop new technical capabilities, knowledge and design concepts (R&D), commercialize new technical capabilities (commercialization), and to manage the evaluation / resolution of issues such as costs, yields, etc.

• Responsibility for delivering assigned projects on-time, on-budget, and meeting all internal and external required specifications. 

• Developing cross-functional plans together with the project team including realistic but aggressive timelines, budgets, and resource planning, risk assessment, and contingency planning.

• Driving requirements, estimating, coordinating engineering and validation, and production, maintaining, and continuously improving processes to coordinate the execution of work.

• Responsible for the organization, facilitation of internal and external project meetings, ensuring communication is transparent so all key stakeholders are aware of progress and critical path tasks / issues.

• Interface with OEMs / external suppliers and design partners to ensure adherence to schedule and quality of delivery.

• Implementing design-to-cost principles to meet cost goals and monitors cost status.

• Preparing and executing countermeasures against schedule, cost scope slips.  Driving the team to “out of box” thinking and creative issue resolution.

• Maintaining control over the project by measuring performance and taking corrective or preventive measures where appropriate.

• Acting as spokesperson for the project, which may include representing the program internally and externally.  Understanding the communication needs and styles of the stakeholders, and responding accordingly.

• Managing to ensure 21CFR820 compliance.

• Developing a risk management plan and executing risk management processes, developing risk responses to eliminate or reduce the probability and impact of project risks.  Ensures that contingency and fallback plans are in place if risk events are realized.  Identifying potential risks and issues for timely escalation to the team or functional manager.

• Ensuring the project meets expectations for manufacturing transfer in terms of design release, procedure readiness, bills of material readiness, etc.  Works with the receiving manufacturing site to ensure that specific requirements are met.

• Completes project closure activities including:  gathering lessons learned, updating records, hands-off of project deliverables, transitioning mutually agreed upon issues to downstream functional groups.

• Identifying opportunities for process improvements.  Propose and establish new product development and project coordination procedures and processes. 

• Experience in BOM and item creation as well as updating documentation such as Engineering Change Orders / Notices (ECOs / ECNs).

Required Competency Skill-Sets:

• Focus on critical deliverables and high priority projects, acting as a hands on resource

• Proactive, results-oriented, self-motivated team player with strong organizational skills and excellent written and verbal communication

• Continuous improvement around developing solutions that offers the highest level of performance at the lowest costs.

• Ability to guide the successful completion of major programs, processes, and projects and take on project leadership role.

• Exhibits exceptional degree of ingenuity, creativity, and resourcefulness. 

• Creates an environment where the skills of individuals are developed and applied creating value for the business. 

• Demonstrated ability to manage teams by influence in a matrix organization and displayed leadership skills.  Teamwork is a must.

• Ability to understand the functions of product development and build partnerships between functions and cultures to accomplish the goals of the project.

• Experience and awareness of industry standards and regulations such ISO 9001 & 13485, GMP, and FDA, etc. and how these relate to internal policies and procedures.

• Ability to multi-task in a changing environment with fluctuating priorities and deadlines

• Drives down to root cause when investigating issues.  When problem solving, considers the broader approach.

• Persistent focus on compliance, quality, and customer and appropriately balances these while striving to achieve key customer centric objectives.

• This position requires hands-on technical skills to understand and manage the resolution of complex project issues.

The ideal candidate will possess:

• Bachelor’s degree required

• PMP certification highly preferred

• Minimum of 3 years of related experience in regulated industry or an advanced degree without experience; or equivalent work experience.

• Minimum 3 years managing complex projects in the medical device regulated industry preferred

• Experience in all phases of product development (feasibility, core development, sustaining, & cost reductions) required 

• Excellent project management, organizational, & planning skills

• Exceptional communication skills (verbal / written / presentation / relationship building), preferred

• Must have good working knowledge of regulations such as FDA GMP section 820 and ISO 9000 section 4.4 for design control.

Benefits:

CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.

• Competitive compensation
• Excellent healthcare including medical, dental, vision and prescription coverage
• Short & long term disability plus life insurance -- cost paid fully by CONMED
• Retirement Savings Plan (401K) -- company match dollar for dollar up to 7% Employee stock purchase plan -- allows stock purchases at discounted price
• Tuition assistance for undergraduate and graduate level courses

CONMED is an Equal Opportunity Employer & an Affirmative Action Employer. CONMED is a strong advocate of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, disability, citizenship status, or veteran status.

If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-325-5900 option #3.