Senior Process Engineer, Advanced Operations

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

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan (ESPP)

Wellbeing program

Tobacco cessation program

Life and AD&D insurance

Short-term disability

Job summary

Stryker is seeking a Senior Engineer, Process Development for its OrthoTech Division. This is an onsite role in Portage, MI, focused on enabling new product introductions through rigorous process validation, testing, and documentation aligned with GMP and company procedures.

The candidate will lead capital projects, perform capability studies, and collaborate with Quality to ensure robust manufacturing processes while guiding manufacturing teams and maintaining compliance with industry standards.

Qualifications

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

Responsibilities

• Provide engineering support for new product and process introductions, ensuring documentation complies with NPD procedures.
• Ensure quality of process and product per specifications.
• Select components and equipment based on specs, reliability and regulatory requirements; develop testing protocols.
• Lead capital acquisition activities including equipment specification, negotiation, installation and validation.
• Analyze equipment to establish operating data and perform tests and analyses.
• Participate in Process FMEA, Control Plans, SOPs and PPAP generation for transfers and launches.
• Complete capability studies for in-process inspection and generate documentation.
• Conduct MSA studies for new products and processes.
• Provide training for manufacturing team members.
• Ensure adherence to GMP and safety procedures.
• Review and approve validation documentation.

Skills

Analytical skills

PFMEA

GD&T

CAD

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.