Senior Manufacturing Engineer

TL;DR

Senior Manufacturing Engineer: Leading hirify.global manufacturing in Grand Rapids clean rooms with an accent on sustaining manufacturing process development, validation strategy execution, and scalable/controlled production. Focus on applying Lean/Kaizen and Six Sigma (DMAIC, VSM, PDCA) while ensuring compliance with 21 CFR 820 and specifying inspection/test requirements for product quality.

Location: Grand Rapids, Michigan, United States of America (Onsite, minimum 5 days/week)

Salary: $102,400.00 - $153,600.00 (USD)

Company

hirify.global is a global healthcare technology company focused on solving challenging health problems.

What you will do

• Lead sustaining manufacturing in Grand Rapids clean rooms and guide junior engineers on processes, equipment use, and manufacturing techniques.
• Develop manufacturing processes applicable to statistical process control and process improvement methods.
• Support validation strategy and execution; design and plan layouts for machining, plastics processing, assembly, and equipment implementation.
• Collaborate on sequence of operations and specify procedures affecting product performance; adapt machine/equipment design to factory and production conditions.
• Ensure inspection and test requirements are specified into the production Control Plan with suppliers and Quality Engineering.
• Investigate equipment/tool deficiencies, initiate corrective actions, and ensure processes are scalable and capable using manufacturability analysis and Gage R&R statistics.

Requirements

• Bachelor’s degree with at least 4 years of relevant experience, or Master’s degree with at least 2 years, or PhD with 0 years.
• Expert understanding of manufacturing technologies and processes with a track record of driving tangible process improvements.
• Experience leading teams and using structured problem solving.
• Knowledge of process improvement techniques such as Business Process Management, Kaizen, DMAIC, Value Stream Mapping, Lean manufacturing, PDCA, and Six Sigma.
• Ability to ensure manufacturing processes comply with regulations including 21 CFR 820.
• Onsite availability: work minimum 5 days/week onsite in Grand Rapids, Michigan.

Nice to have

• 5+ years of Manufacturing Engineering experience.
• GDP/GMP; validation planning and execution experience.
• Process mapping / Control plan generation; ability to review and update drawings.
• Experience creating FMEAs; statistical analysis using Minitab.
• CAD experience (e.g., Solidworks); working knowledge of Agile Map.
• Experience with SAP; supplier engagement; medical device industry experience with 13485/FDA requirements.

Culture & Benefits

• Onsite role with in-person collaboration (minimum 5 days/week).
• Eligible for short-term incentive (hirify.global Incentive Plan, MIP).
• Health, dental, and vision insurance plus Health Savings Account and Healthcare Flexible Spending Account.
• 401(k) plan with employer contribution and match; paid time off and paid holidays.
• Tuition assistance/reimbursement and well-being program (Simple Steps).
• Additional benefits for regular employees working 20+ hours/week, including life insurance and long-term disability leave.

Hiring process

• Application review against minimum requirements on the resume.
• Interviews to assess leadership behaviors, manufacturing/process improvement expertise, and structured problem-solving experience.
• Final evaluation of fit for onsite sustaining manufacturing responsibilities and compliance expectations.