Production Product Manager

Job Description

Job Description

Join Us as a Product Manager – Lead, Innovate, and Deliver Excellence

We are seeking an experienced Product Manager to oversee the full manufacturing lifecycle of a key medical device. In this critical role, you’ll serve as the bridge between product management, operations, quality, regulatory, and engineering — ensuring products are manufactured efficiently, meet FDA and ISO standards, and consistently deliver on quality, safety, and reliability.

If you thrive on turning complex challenges into streamlined solutions, and you want your work to have a direct impact on patient care and product success, this is your opportunity.

What You’ll Do

Oversee the full production lifecycle for assigned medical device products, aligning production, quality, regulatory, and delivery goals.

Serve as the primary liaison across project management, manufacturing, quality, regulatory, and engineering teams.

Ensure compliance with FDA (21 CFR Part 820) , ISO 13485 , and other applicable regulations.

Lead production readiness for new product introductions (NPI) , including documentation, tooling, training, and process optimization.

Monitor production metrics (yield, throughput, quality, delivery) and drive improvements.

Manage engineering change orders (ECOs) and maintain accurate production documentation (DMRs, BOMs, work instructions).

Drive continuous improvement initiatives for cost, manufacturability, and quality.

Collaborate with Supply Chain to ensure material readiness and resolve supply constraints.

Participate in internal and external audits as needed.

What We’re Looking For

Bachelor’s degree in Engineering, Life Sciences, Operations, or related field (or equivalent experience).

3+ years in medical device manufacturing, product management, or operations within regulated environments.

Strong knowledge of FDA QSR and ISO 13485 requirements.

Proven success leading cross-functional teams from development through production.

Supervisory experience in manufacturing.

Strong analytical, organizational, and problem-solving skills.

Proficiency in Microsoft Office 365; ERP / MRP knowledge is a plus.

Experience with Lean, Six Sigma, or other process improvement methods preferred.

Why You’ll Love It Here

Be a key player in life-changing medical device production .

Collaborate with an exceptional cross-functional team.

Competitive pay, comprehensive benefits, and professional growth opportunities.

A culture committed to quality, innovation, and compliance .

Ready to take ownership of a product’s journey from production floor to patient impact?

Apply now and help us set the standard for manufacturing excellence in the medical device industry.