PD Program Manager (Medtech)

TL;DR

PD Program Manager (Medtech): Lead released product management and sustainment programs for energy-based medical devices with an accent on regulatory compliance and technical engineering insights. Focus on executing projects throughout the lifecycle using Monte Carlo simulations and ensuring strict adherence to FDA and ISO standards.

Location: Onsite in Lafayette, Colorado, USA

Salary: $163,000 – $204,000 per year

Company

hirify.global is a global leader in medical technology, developing innovative healthcare solutions to alleviate pain, restore health, and extend life.

What you will do

• Lead released product management (RPM) and sustainment programs for energy-based medical devices.
• Assess design and process impacts for changes related to field complaints and supplier component updates.
• Coordinate Voice of Customer (VOC) activities and manage formative and summative studies.
• Ensure absolute compliance with FDA QSR 21 CFR 820, ISO 13485, and other medical device regulations.
• Utilize Monte Carlo simulations to quantify risks across design, development, and production phases.
• Drive system enhancements and troubleshoot issues within SAP S/4HANA, SAP ECC, and HP ALM.

Requirements

• Bachelor’s in Mechanical, Industrial, or Biomedical Engineering with 5+ years of experience, or a Master’s with 2+ years.
• Must be located in or able to work onsite in Lafayette, Colorado.
• Minimum 2 years of experience with FDA QSR 21 CFR 820, ISO 13485, ISO 10993, and IEC 62366.
• Proven experience with SAP S/4HANA/ECC, HP ALM, and IQ/OQ/PQ validation protocols.
• Expertise in Design for Injection Molding, extrusion, CNC machining, and tolerance stack-up analysis.
• Required: Certified Six Sigma Black Belt (ASQ or equivalent certifying agency).

Nice to have

• Proficiency in CAD tools including PTC Creo, Minitab, SolidWorks, and AutoCAD.
• Experience with Cerebrospinal Fluid (CSF) and cranial products.
• Experience with Design of Experiments (DOE) and the CAPA process.

Culture & Benefits

• Comprehensive healthcare package including dental, vision, HSA, and Flexible Spending Account.
• Financial security through a 401(k) plan with employer contribution and match.
• Generous paid time off and paid holidays.
• Employee Stock Purchase Plan and Non-qualified Retirement Plan Supplement.
• Support for continuous learning via tuition assistance and reimbursement.
• Global well-being program (Simple Steps).