Process Engineer

Manufacturing Engineer

As a key member of the Product Transfer Team, the Manufacturing Engineer is responsible for the seamless integration of new products into existing assembly lines. This role focuses on developing and validating manufacturing processes, ensuring they meet quality, safety, and efficiency standards.

Key Responsibilities:

• Develop and implement manufacturing processes on existing assembly lines for new product introductions.
• Lead equipment and machine validation efforts, including process validation (IQ/OQ/PQ).
• Create comprehensive documentation including work instructions, PFMEAs, control plans, and engineering specifications.
• Design and optimize line layouts with a focus on ergonomics and job hazard assessments.
• Conduct torque studies and program torque controllers to ensure process accuracy and repeatability.
• Develop Preventive Maintenance (PM) procedures for new and existing equipment.
• Prepare and submit PPAP documentation in compliance with customer and regulatory requirements.
• Generate technical views and documentation of the assembly process and line configuration.
• Drive the creation and execution of a Plan for Every Part to ensure material readiness and flow.
• Provide engineering support for product transfers ensuring that all activities are completed and documented in accordance with the latest Stryker procedures. Determine the technical objectives of engineering assignments and makes decisions regarding the direction and the results of the assignment.
• Monitor and control progress of work ensuring sound application of engineering principles and the appropriate use of policies and procedures.
• Analyze equipment to establish operating data, conduct experimental test and result analysis. May lead or act as independent reviewer in process review meetings. Coach and mentor others on functionally related topics. Ensure quality of process and product as defined in the appropriate operation and material specifications.
• Select components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols. Participate in PFMEA, Control Plan, SOP, PPAP and other internal process qualification generation associated with product transfers.
• Ensure adherence to GMP and safety procedures.
• Review and approve of validation documentation.

Qualifications:

• Bachelors degree in an engineering discipline.
• Minimum of 4 or more years experience in a FDA regulated manufacturing or project environment.
• Experience of process/ product validation. Experience with statistical methods, process mapping, root cause analysis.
• Experience in executing complex problem-solving techniques related to manufacturing technical issues.

Job Type & Location:

This is a Contract position based out of Portage, MI.

Pay and Benefits

The pay range for this position is $55.00 - $67.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Portage,MI.

Application Deadline

This position is anticipated to close on Oct 21, 2026.