Senior Manufacturing Engineer

Stryker • Flower Mound, TX

10d • Onsite

About The Position

Stryker is looking for a Senior Manufacturing Engineer to make a meaningful impact on how life changing products are built and launched. This is an onsite role in Flower Mound, TX. The role involves developing the overall manufacturing approach for new products and line extensions, owning key manufacturing deliverables, and leading engineering projects. The engineer will also design, build, or source fixtures, equipment, and tools, and manage Engineering Change Orders (ECOs). Compliance with GMP, 21 CFR 820, and ISO 13485 is essential. This position also includes mentoring junior engineers, analyzing production variables, and participating in supplier selection and validation. Cost-reduction initiatives, product sustainment, and supporting international product releases are also key aspects of the role.

Requirements

• B.S. in engineering (mechanical, electrical, biomedical, industrial or software preferred).
• 2+ years of relevant full-time work experience.
• Demonstrated ability to operate small hand tools (e.g. pliers, screwdrivers, hammer, wrenches, etc.), power tools and test/inspection equipment.
• Demonstrated mechanical/electrical or software problem solving skills.

Nice To Haves

• Lean Manufacturing experience preferred.

Responsibilities

• Develop the overall manufacturing approach for new products and line extensions within new product development and specials processes.
• Own key manufacturing deliverables, including Manufacturing Plan Review, Pre‑Pilot, Serviceability Review, Process Validation, Final Cost Roll, PPQA Phase 3, and post‑launch deliverables; contribute to PPQA Phases 1–2.
• Lead engineering projects, tracks progress, provide status updates, anticipate risks, and drive issue resolution.
• Design, build, or source fixtures, equipment, and tools to ensure product quality and cost effectiveness.
• Initiate, review, document, and approve Engineering Change Orders (ECOs); participate in CAPA and internal audits; ensure GMP, 21 CFR 820, and ISO 13485 compliance.
• Mentor manufacturing and junior engineers, lead analysis of production variables (e.g., rework, scrap, warranty), and train others on manufacturing engineering topics.
• Participate in supplier and OEM selection, validation, customization, and issue resolution, and support vendor quality and manufacturing activities.
• Identify, implement, and report on cost‑reduction initiatives and support ongoing product sustainment, revisions, and material obsolescence efforts.
• Support international product releases, regulatory understanding, training development, customer interactions, and exercise authority to make decisions impacting operations and the broader organization.

Benefits

• Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees