Engineer, Process/Validation (Medtech)

TL;DR

Engineer, Process/Validation (Medtech): Developing and optimizing manufacturing processes and equipment for commercial release with an accent on validation protocols and FDA compliance. Focus on executing IQ/OQ/PQ, managing process risk documentation (pFMEA), and ensuring seamless transfer of equipment into production.

Location: Hybrid (1-2 days at home), must be based in Fraser, MI, US

Salary: $75,120–$93,900 annually + 4% STIP

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows.

What you will do

• Develop and optimize manufacturing processes and equipment for new product commercial release.
• Prepare and execute protocols for Installation Qualifications (IQ), Operational Qualifications (OQ), Test Method Validations (TMV), and Performance Qualification (PQ).
• Assist with the preparation of process risk documentation (pFMEA) and coordinate pilot production.
• Collaborate with Manufacturing to release and support new processes and equipment in production.
• Manage change orders (ECO/DCO) and maintain strict compliance with Quality System regulations.
• Create and implement essential documentation, including equipment history files, manufacturing procedures, and BOMs.

Requirements

• Bachelor’s Degree in Engineering.
• Minimum 3 years of experience in the medical device industry.
• Strong problem-solving and troubleshooting skills.
• Ability to prepare professional written reports and communicate effectively in cross-functional teams.
• Knowledge of and ability to comply with U.S. and Worldwide medical device regulations (FDA).
• Proficiency in MS Office Suite (Word, Excel).

Nice to have

• Experience with introducing new equipment or processes into production.
• Experience with process control and statistical analysis techniques.

Culture & Benefits

• Comprehensive Health, Dental, and Vision insurance.
• 401k plan with company match.
• Paid Time Off and Parental/Caregiver Leave.
• Tuition Reimbursement and Wellness initiatives.
• Life insurance, Short-term and Long-term Disability benefits.
• Commuter benefits and Dependent Care Flexible Spending Accounts.