Engineering Manager (Medtech)

TL;DR

Engineering Manager (Quality/Medtech): Leading the Returned Product Analysis (RPA) lab to ensure cardiac ablation products remain safe and effective with an accent on laboratory operations and regulatory compliance. Focus on managing technical teams, driving root cause analysis, and ensuring system reliability for post-market quality.

Location: Onsite in Minnesota or Massachusetts, USA

Salary: $142,400 - $213,600

Company

A global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life through innovative medical solutions.

What you will do

• Manage daily operations of the Returned Product Analysis (RPA) laboratory, including sample intake, testing, and reporting.
• Direct and manage a technical team supporting returned complaint product and data analysis for Cardiac Ablation Solutions.
• Oversee laboratory equipment qualification, calibration, and maintenance.
• Partner with Quality Engineering, Manufacturing, R&D, and Regulatory teams to support investigations and corrective actions (CAPA).
• Lead, coach, and develop RPA laboratory staff, including hiring, onboarding, and performance management.
• Drive consistent root cause analysis and implement process improvements to increase investigation efficiency.

Requirements

• Bachelor's degree in Engineering, Science, or Technical Field with 5+ years of experience, or an Advanced degree with 3+ years.
• Must possess unrestricted U.S. work authorization at the time of hire.
• Experience in highly regulated industries, preferably Class III implantable medical devices.
• Knowledge of quality system regulations such as 21 CFR 820, European MDR, ISO 13485, and ISO 14971.
• Proven critical thinking and structured problem-solving skills to improve system performance.
• Ability to travel up to 25% domestically and internationally.

Nice to have

• Direct leadership experience managing tasks for other individuals.
• Knowledge of Lean, Six Sigma, and Design for Reliability and Manufacturability (DRM).
• Experience working across different geographies and cultures.

Culture & Benefits

• Competitive salary and eligibility for the hirify.global Incentive Plan (MIP).
• Comprehensive health, dental, and vision insurance, including HSA and Healthcare Flexible Spending Accounts.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and tuition assistance/reimbursement.
• Employee Stock Purchase Plan and a global well-being program (Simple Steps).