Manufacturing Engineer

Job Description

Pay range: 35-45/hr

* depending on experience

As a member of the U.S. Orthopedics Operations Engineering team, you'll lead the planning and execution of manufacturing transfers across our global network. You'll coordinate technical readiness, validation activities, and process documentation to ensure smooth transitions between manufacturing sites-while maintaining world-class standards for quality, safety, and compliance.

• Execute end-to-end manufacturing and site transfer projects, including planning, risk assessment, validation, and handover.
• Coordinate all technical documentation, process flows, and equipment readiness activities at both sending and receiving sites.
• Support process and equipment validation (IQ/OQ/PQ) and ensure compliance with FDA and ISO 13485 requirements.
• Partner cross-functionally with Quality, Regulatory, Supply Chain, Manufacturing, and R&D to ensure alignment and readiness.
• Lead root cause analysis and technical problem-solving throughout the transfer lifecycle.
• Prepare and maintain project documentation, including validation protocols, reports, and change control packages.
• Communicate project progress, risks, and mitigation strategies to stakeholders at all levels.
• Capture and share lessons learned to continuously improve future transfer processes.

Success in this role requires technical expertise, attention to detail, and a collaborative mindset. You should be comfortable managing multiple priorities in a fast-paced, regulated environment.

• Bachelor's degree in engineering, science, or related discipline.
• Minimum of 4 years of experience in medical device manufacturing or other regulated industries.
• Proven track record leading or supporting site or manufacturing transfers.
• Or, proven track record of new product launches into existing sites.
• Strong knowledge of process validation, change control, and manufacturing documentation.
• Excellent problem-solving, communication, and organizational skills.
• Ability to work independently and drive results with minimal supervision.

• Experience with orthopedic implants, instruments, or precision assembly.
• Familiarity with lean manufacturing and Six Sigma methodologies.
• Proficiency with ERP, PLM, or MES systems.

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate.

We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (, , and ) and not a domain with an alternative extension like .net,

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Manufacturing Engineer
• Austin, TX, United States