Senior Process Engineer, Advanced Operations

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

Benefits offered by this job

Health benefits

HSA

FSAs

401(k) plan

Employee Stock Purchase Plan (ESPP)

Life and AD&D insurance

Short-term disability

Wellbeing program

Job summary

Stryker, a leading medical technology company, seeks a Senior Engineer, Process Development to join its OrthoTech Division in Portage, MI. This onsite role emphasizes new product introductions, process development, and GMP compliance, partnering with design and manufacturing teams to drive quality and efficiency.

Responsibilities include PFMEA, DOE studies, equipment validation, capital projects, and training manufacturing personnel, with travel to sites as needed.

Qualifications

• Bachelor's degree in engineering required.
• 2+ years of full-time work experience required.
• PFMEA experience required.
• Ability to read and interpret GD&T drawings.
• Strong documentation and cross-functional communication skills.
• Willingness to travel between sites.

Responsibilities

• Support new product and process introductions, ensuring activities are documented per NPD procedures.
• Ensure quality of process and product.
• Support supply chain architecture and implementation to meet project needs.
• Own process development and validation for the entire supply chain.
• Communicate DFM, DFA, and DFI considerations with designers and suppliers.
• Lead/select components based on specs, reliability and regulatory requirements.
• Develop testing and inspection equipment and protocols.
• Lead capital acquisition: equipment specs, contracts, installation and validation.
• Analyze equipment data, conduct tests and result analysis; participate in reviews.
• Own PFMEA/PCP and validation planning/execution per quality system.
• Complete DOE, MSA, capability studies for component and assembly processes.
• Provide training for manufacturing teams.
• Ensure adherence to GMP and safety procedures.

Skills

PFMEA knowledge

GD&T interpretation

Cross-functional communication

Analytical skills

Engineering documentation

Machining/manufacturing knowledge

Reading engineering drawings

Travel willingness

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:

• Support 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.
• Support supply chain architecture and implementation to deliver on project needs and business strategy.
• Own process development and validation for the entire supply chain.
• Partner with designers and suppliers to communicate DFM, DFA, and DFI considerations.
• Select components and equipment based on analysis of specifications, reliability and regulatory requirements.
• Develop testing and inspection equipment and 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.
• Own process risk documentation (PFMEA, PCP) and validation planning/execution per Stryker quality system requirements.
• Complete engineering studies (DOE, MSA, capability, etc.) for component and assembly manufacturing and inspection processes.
• Provide training for manufacturing team members.
• Ensure adherence to GMP and safety procedures.

What you need:

• Bachelor's degree in engineering required
• 2+ years of applicable full-time work experience required
• Working knowledge of PFMEA required
• Strong technical documentation skills with ability to communicate technical detail effectively to a cross-functional audience.
• Excellent analytical skills, ability to plan, organize, and implement concurrent tasks required
• Good knowledge of machining/manufacturing/assembly processes, materials, product and process design required
• Ability to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing (GD&T) required
• Ability to learn and apply quality system procedures and best practices.
• Strong interpersonal & communication skills for cross-functional internal and external conversations.
• Willingness to travel between Stryker engineering and manufacturing sites, as well as key supplier sites, on an as-needed basis.
• CAD experience

United States of America Pay Ranges:

• USN: $77,700 - $129,500 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

Health benefits:

• 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:

• Health Savings Account (HSA)
• Flexible Spending Accounts (FSAs)
• 401(k) plan
• Employee Stock Purchase Plan (ESPP)
• Basic life and AD&D insurance
• 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.

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