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Manufacturing Engineer II – Austin, TX – Orthopedics

Join an innovation-focused orthopedic medical device company seeking a Manufacturing Engineer II to bring hands-on production expertise to its growing product pipeline.

Reporting to the Vice President of Manufacturing Operations, this highly visible role will own supplier management, lead non-conformance investigations and CAPAs, and bring a design for manufacturing (DFM) perspective to new product development.

Responsibilities:

• Serve as the primary engineering contact for contract manufacturers (CMOs), owning supplier management, tracking, and quoting, with particular focus on the instrument and surgical set supplier base.
• Lead non-conformance investigations with suppliers, using hands-on manufacturing knowledge to find the root cause of what happened and why, and document the findings thoroughly.
• Drive CAPAs and SCARs through to closure, and support manufacturing issues and audits.
• Apply design for manufacturing (DFM) principles to reduce supplier and design-related issues, partnering with design engineers to improve manufacturability, quality, and cost.
• Evaluate supplier manufacturing capabilities and readiness for new products, and support supplier selection, onboarding, qualification, and audits.
• Review and approve supplier process validation protocols and reports, making sure manufacturing processes meet design and regulatory requirements.
• Serve as a core member of new product development (NPD) teams: lead the operations side of projects, develop design inputs and manufacturing flows, contribute to project plans, and keep milestones on time, on budget, and to quality expectations.
• Manage and maintain Device Master Records (DMRs), identifying opportunities to streamline them and make them more efficient.
• Create, review, and approve engineering change orders (ECOs), and manage deviations.
• Develop and document internal manufacturing processes and establish supplier quality standards.
• Build strong relationships with suppliers and troubleshoot manufacturing and quality issues as they arise.

Qualifications:

• 5+ years of manufacturing engineering experience in the medical device industry required, ideally with finished goods products.
• Orthopedic manufacturing experience is strongly preferred, and instrument and surgical set experience is highly valued.
• Proven, hands-on experience leading non-conformance investigations, root cause analysis, and CAPAs using quality and statistical tools, grounded in a strong understanding of manufacturing and not only documentation.
• Demonstrated supplier management experience, including work with contract manufacturers, quoting, supplier qualification, and supplier quality.
• Strong knowledge of manufacturing and new product processes, particularly machining, and of DFM principles.
• Working knowledge of FDA process validation requirements, FDA QSR design controls, GMP, and ISO standards.
• Familiarity with ECO and deviation processes, DMR management, drafting standards, and geometric dimensioning and tolerancing (GD&T).
• Bachelor’s degree in Mechanical or Industrial Engineering, or another engineering science, required; an equivalent combination of education and experience will be considered.
• Strong written, verbal, and technical presentation skills, and proficiency in MS Office.

Compensation:

• Base Salary: Competitive
• Comprehensive Benefits Package
• Location: Austin, TX
• Approximately 15–20% travel required

The job description is not exhaustive and may have been condensed for online or mobile viewing. It does not encompass all duties, responsibilities, or aspects of the job and is subject to amendments at the sole discretion of the Employer. Employees may also perform other related duties as needed to support the organization.

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