Medical Device NPI Leader: Cross-Functional Launch

Marmon Group

Angola (IN)

On-site

USD 110,000 - 160,000

Full time

14 days+

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Job summary

Precision Edge Surgical Products Company LLC, part of Marmon Group, is seeking a Manager of New Product Introductions to lead the engineering team in transferring medical device products from development to commercial manufacturing. You will coordinate with multiple functions to ensure on-time, budget-compliant launches and regulatory alignment.

The ideal candidate brings extensive experience in medical device development and manufacturing operations, plus strong project management and

Qualifications

Bachelor's degree in engineering (Required).
10–15 years in medical device contract manufacturing, product development, and launch (Required).
Knowledge of ISO 13485 and 21 CFR 820 (Required).
Supervisory experience leading teams (Required).
Ability to use SolidWorks, ERP, Smartsheet, and SharePoint (Required).
Advanced degree in engineering (Preferred).
Experience in cost estimating and prototype processes (Preferred).

Responsibilities

Lead engineering team in transferring new medical device products from development to commercial manufacturing.
Coordinate NPI process from customer request to product launch or handoff to on-site teams.
Collaborate with Business Development, Quality, Procurement, Supply Chain, Manufacturing, Accounting, and external suppliers.
Understand manufacturing processes and capabilities across MMM sites.
Develop and maintain a formal prototype process using nonproduction equipment.
Provide training and establish goals aligned with company objectives.
Support budgeting and strategic planning.
Contribute to Monthly Management Report analysis.
Champion Health, Safety and Environment standards.