Senior Manufacturing Engineer

Stryker • Flower Mound, TX

2d • 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 Senior Manufacturing Engineer will develop the overall manufacturing approach for new products and line extensions within new product development and specials processes. They will own key manufacturing deliverables, including Manufacturing Plan Review, Pre‑Pilot, Serviceability Review, Process Validation, Final Cost Roll, PPQA Phase 3, and post‑launch deliverables; and contribute to PPQA Phases 1–2. This role involves leading engineering projects, tracking progress, providing status updates, anticipating risks, and driving issue resolution. The engineer will design, build, or source fixtures, equipment, and tools to ensure product quality and cost effectiveness. Responsibilities also include initiating, reviewing, documenting, and approving Engineering Change Orders (ECOs); participating in CAPA and internal audits; and ensuring GMP, 21 CFR 820, and ISO 13485 compliance. Additionally, the role involves mentoring manufacturing and junior engineers, leading the analysis of production variables (e.g., rework, scrap, warranty), and training others on manufacturing engineering topics. The engineer will participate in supplier and OEM selection, validation, customization, and issue resolution, and support vendor quality and manufacturing activities. They will identify, implement, and report on cost‑reduction initiatives and support ongoing product sustainment, revisions, and material obsolescence efforts. The role also supports international product releases, regulatory understanding, training development, customer interactions, and exercises authority to make decisions impacting operations and the broader organization.

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

• Stryker Corporation is an equal opportunity employer. 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.
• Stryker is an EO employer – M/F/Veteran/Disability.
• Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
• Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better.
• We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.
• We are proud to be named one of the World’s Best Workplaces!

What This Job Offers

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