Senior Staff Engineer, Advanced Operations

Stryker; Portage (MI); On-site; USD 103,000 - 171,000; Full time

Job summary

Stryker in Portage, MI is recruiting a Senior Staff Process Engineer, Advanced Operations to transfer innovative surgical product designs from R&D into production, with emphasis on plastic injection molding and transfer molding.

The role leads process development, defines specifications, conducts capability studies, and collaborates with cross-functional teams to launch high-quality products on schedule. This onsite position requires 6+ years of experience and strong GMP discipline.

Qualifications

• Bachelor's degree in engineering.
• 6+ years of manufacturing or process engineering experience.
• Expertise in plastic injection molding, polymers, and plastic assembly methods (adhesives, welding).
• Ability to read and interpret complex engineering drawings and GD&T.
• Experience solving manufacturing/design technical issues with good judgement.
• Ability to lift up to 20 pounds.
• Ability to work with small components and hand tools.

Responsibilities

• Design Transfer: support new product and process introductions for plastic injection molding.
• Process & Quality Assurance: define specs, perform capability studies, generate inspection docs.
• Equipment & Component Selection: evaluate components and equipment per specs, develop test protocols with QA.
• Capital Acquisition: lead from equipment spec to installation and validation.
• Problem Solving: conduct root cause analyses and validation testing.
• Documentation & Compliance: create/approve validation docs, ensure GMP/safety compliance.
• Team Training: train manufacturing teams on new processes and technologies.

Skills

Manufacturing engineering

Process engineering

Plastic injection molding

Reading engineering drawings

Problem solving

Hands-on with tools

Education

Bachelor's degree in engineering

Tools

CAD

Inspection equipment

Job description

As a Senior Staff Process Engineer, Advanced Operations, you will play a pivotal role in transferring cutting-edge surgical product designs from R&D into production. This position requires expertise in process development, specifically with transfer molding and related technologies. Collaborating with cross-functional teams, you will ensure the seamless launch of high-quality products, enhancing both patient outcomes and operational efficiency. This is an onsite position in Portage, MI.

What you will do:

• Design Transfer: Support new product and process introductions, ensuring adherence to Stryker's new product development protocols, with a focus on plastic injection molding.
• Process & Quality Assurance: Guarantee process and product quality by defining and adhering to specifications, conducting capability studies, and generating inspection documentation.
• Equipment & Component Selection: Evaluate components and equipment based on specifications, reliability, and regulatory requirements, and collaborate with quality engineers to develop testing protocols.
• Capital Acquisition: Lead activities from equipment specification and negotiation to installation and validation.
• Problem Solving: Conduct root cause analyses, process reviews, and experimental tests, leveraging statistical and validation techniques.
• Documentation & Compliance: Create and approve validation documentation, ensuring compliance with GMP and safety standards.
• Team Training: Provide training to manufacturing team members on new processes and technologies.

What you need:

• Bachelor's degree in engineering
• 6+ years of manufacturing engineering or process engineering experience required
• Expertise in plastic injection molding, polymers, and plastic assembly methods (e.g., adhesives, welding)
• Ability to read and interpret complex engineering drawings and can understand geometrical dimension and tolerances
• Experience in executing complex problem-solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design
• Ability to lift up to 20 pounds to move equipment.
• Ability to work with and assemble small objects and component parts.
• Ability to operate small hand tools, inspection equipment, and other office equipment.

Preferred skills:

• Tooling design experience
• Experience in R&D, new product development, or process design
• Experience in an FDA regulated or regulated industry
• CAD experience
• Good understanding of Design for Manufacturing related statistical tools and validation/verification techniques

$102,600 - $171,000 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.