The Planet Group

Job Description

A Validation Engineer responsible for the development/authoring Validation Plans (VP) and protocols for all phases of the validation lifecycle execution of test protocols and analysis of data using statistical techniques, tools and software.

Required:

• 3-5 years’ experience in Medical Device manufacturing is preferred
• Bachelor’s degree in engineering or engineering technology (Mechanical, Electrical, Biomedical)
• Knowledgeable on ISO13485, regulatory requirements, and FDA 21 CFR 820/GMP Medical Device Regulations
• Experience with different manufacturing processes, such as automated assembly lines, manual assembly processes, molding processes and packaging processes.

Skills and Responsibilities:

• Validation experience, process and equipment qualification (IQ, OQ, PQ), Test Methods & GR&R’s
• Process development/characterization experience
• Ability to analyze data through the use of statistical principals (e.g. process capability, normality test, GR&R, etc.) and statistical software (e.g. Minitab)
• Ability to compose professional and engineering documentation (e.g. protocols, engineering studies, reports, etc.)
• Ability to manage time and projects effectively while setting and meeting aggressive schedules
• Quality oriented individual with a focus on making data driven decisions
• Proficient with the use of Microsoft tools (Word, Excel, Project, Power Point, Visio)
• Ability to understand business, legal and regulatory requirements

Great benefits and profit-sharing opportunity!

At The Planet Group, we connect Engineering experts with opportunities that match their skills, goals, and ambition. From fast-moving startups to global enterprises, we partner with top organizations across industries—giving you access to roles where your contributions make a difference. Explore flexible options including contract, direct hire, and contract-to-hire, all supported by a team that puts people first.

The staffing 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 domain (@theplanetgroup.com or @launchcg.com) - and not a domain with an alternative extension like .net, .org or .jobs.

The Planet Group and our companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.