Senior Process Engineer, Advanced Operations

Stryker; Portage (MI); On-site; USD 78,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

HSA

FSAs

401(k) plan

ESPP

Life insurance

Short-term disability

Wellbeing program

Tobacco cessation program

Job summary

Stryker in Portage, MI is seeking a Senior Engineer, Process Development to join its OrthoTech Division. This onsite role focuses on supporting new product introductions, process development, and capital equipment projects to ensure compliant, efficient manufacturing.

You will analyze processes, perform capability studies, PFMEA, control plans, and validation documentation, while training teams and upholding GMP and safety standards.

Qualifications

• Bachelor’s degree in engineering required.
• 2+ years of applicable full-time work experience required.
• Working knowledge of PFMEA required.
• Ability to read and interpret engineering drawings and GD&T.
• CAD experience required.

Responsibilities

• Provide engineering support for new product and process introductions per NPD procedures.
• Ensure process and product quality per specifications.
• Lead equipment selection and capital acquisitions, installation and validation.
• Analyze equipment data, conduct experiments, and generate results.
• Participate in PFMEA, Control Plan, SOP, and PPAP for transfers and launches.
• Complete capability studies and generate inspection documentation.
• Conduct MSA studies for new products and processes.
• Provide training to manufacturing teams and ensure GMP compliance.

Skills

Analytical skills

Planning & organization

Concurrent task management

Reading engineering drawings

GD&T understanding

Education

Bachelor’s degree in engineering

Tools

CAD

Job description

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Senior Engineer, Process Development to join our OrthoTech Division. This is an onsite position in Portage, MI.

What you will do:

• Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures.
• 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.
• Lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
• Analyze equipment to establish operating data, conduct experimental test and result analysis. Lead and/or participate in process review meetings.
• Participate in Process Failure Mode and Effect Analysis, Control Plan, SOP and Production Part Approval Process generation associated with product transfers and launches.
• Complete capability studies for in process inspection and generate subsequent Inspection documentation.
• Conduct MSA studies for new products and new processes.
• Provide training for manufacturing team members.
• Ensure adherence to GMP and safety procedures.
• Review and approval of validation documentation.

What you need:

• Bachelor’s degree in engineering required
• 2+ years of applicable full-time work experience required
• Working knowledge of PFMEA required
• Excellent analytical skills, ability to plan, organize, and implement concurrent tasks required
• Good knowledge of manufacturing processes, materials, product and process design required
• Ability to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing (GD&T) required
• CAD experience

$77,700 - $129,500 USD Annual

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.