NPI Manager: Medical Device Launch and Manufacturing

Precision Edge Surgical Products Co

Angola (IN)

On-site

USD 120,000 - 180,000

Full time

14 days+

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Job summary

Precision Edge Surgical Products Company LLC is seeking an experienced NPI Manager to lead engineering teams through transferring new medical devices from development to commercial manufacturing. You will coordinate across Business Development, Quality, Procurement, and Supply Chain to ensure on-time, on-budget launches in a regulated environment.

The ideal candidate will have 10-15 years in medical device contract manufacturing, fabrication, and product launches, with ISO 13485 and 21 CFR 820

Qualifications

Bachelor’s degree in engineering
10-15 years’ experience in medical device contract manufacturing, product development and production launch
Knowledge of ISO 13485 and 21 CFR 820
Supervisory experience leading teams
Ability to use SolidWorks, navigate ERP software, utilize workflows such as Smartsheet and SharePoint

Responsibilities

Lead engineering team in the successful transfer of new medical device products from development into commercial manufacturing.
Coordinate and manage the NPI process from customer request to product launch or launch handoff to onsite engineering teams.
Work with Business Development, Quality, Procurement, Supply Chain, Operations, Accounting, and Procurement to meet company goals.
Develop and maintain a formal prototype process utilizing nonproduction equipment.
Create a team-based environment with a positive atmosphere.
Assist annually with the budget setting process and strategic planning.
Support Monthly Management Report (MMR) analysis and generation.
Champion Health, Safety and Environment standards