Engineering Project Manager
Company: CONMED Corporation
Location: Largo
Posted on: January 16, 2023
Job Description:
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. This is an onsite
role.
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:
- Bachelor's degree or equivalent
The ideal candidate will possess:
- 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)
- Excellent project management, organizational, & planning
skills
- Exceptional communication skills (verbal / written /
presentation / relationship building), preferred
- A good working knowledge of regulations such as FDA GMP section
820 and ISO 9000 section 4.4 for design control.
- Expected travel 20%This position is not eligible for
employer-visa sponsorship
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
coursesCONMED 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.
#LI-Onsite
Keywords: CONMED Corporation, Largo , Engineering Project Manager, Executive , Largo, Florida
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