Job summary
Job post source
This job is directly from Zimmer Biomet
Job overview
The Process Engineer Sr I at Zimmer Biomet supports validation activities to ensure compliance and quality in medical device manufacturing, impacting product reliability and patient mobility.
Responsibilities and impact
The role involves collecting and reviewing data for process and test method validations, drafting validation protocols and reports, preparing and reviewing supporting documentation, coordinating approvals, writing and executing validation plans and protocols, and managing validation projects.
Experience and skills
Requires a Bachelor's in Engineering or related field, at least 3 years of relevant experience, 2 years working with FDA and ISO 13485 regulations, in-vitro diagnostics, and statistical sampling, plus 1 year in Test Method Validation.
Career development
Zimmer Biomet offers development opportunities, employee resource groups, and a culture of recognition to support career growth.
Work environment and culture
The company promotes an inclusive, respectful, and empowering work environment with flexible working conditions and wellness incentives.
Company information
Zimmer Biomet is a global medical technology leader with nearly 100 years of history, enhancing patient mobility worldwide every 8 seconds.
Job location and travel
The position is located at CD Diagnostics Inc., Claymont, DE, with up to 5% domestic travel and standard weekday hours.
Company overview
Zimmer Biomet is a global leader in musculoskeletal healthcare, specializing in designing, manufacturing, and marketing orthopedic reconstructive products, including joint replacement implants, surgical tools, and biologics. The company generates revenue through the sale of these medical devices and solutions to hospitals, surgical centers, and healthcare providers worldwide. Founded in 1927, Zimmer Biomet has a rich history of innovation and mergers, including the significant merger of Zimmer Holdings and Biomet, Inc. in 2015, which expanded its product portfolio and market reach.
How to land this job
Position your resume to highlight at least three years of experience in process engineering or related roles, emphasizing your expertise in validation activities such as IQ/OQ/PQ protocols and test method validations.
Focus on showcasing knowledge and hands-on experience with FDA and ISO 13485 regulations, particularly in the medical device or in-vitro diagnostics field, as well as proficiency in statistical sampling, blueprint reading, and geometrical dimensions and tolerances.
Apply through multiple channels including Zimmer Biomet's corporate careers site, LinkedIn job postings, and other reputable job boards to maximize application visibility.
Connect on LinkedIn with current Zimmer Biomet employees in the diagnostics or process engineering divisions; start conversations by referencing Zimmer Biomet’s commitment to innovation or asking about their experience working with FDA/ISO compliance.
Optimize your resume for ATS by incorporating keywords such as 'validation protocols,' 'FDA regulations,' 'ISO 13485,' 'test method validation,' 'statistical sampling,' and 'process validation' to ensure it passes automated screening.
Leverage Jennie Johnson's Power Apply feature to automate tailored resume customization, multi-channel applications, and targeted LinkedIn networking, allowing you to focus your energy on interview preparation and skill development.
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