What are the responsibilities and job description for the Process Validation Engineer position at Ortho Development Corporation?
Process Validation Engineer
Are you looking for a great work culture, good teammates, and caring leadership? Ortho Development is the place to be. We offer great benefits, working Monday through Friday. Ortho Development Corporation helps people do what they love by restoring mobility. We are an orthopedic design, manufacturing and distribution company located in Draper, Utah. We offer a complete benefits package, clean work environment, and thorough training.
As the Process Validation Engineer, you will be responsible for planning, executing, and maintaining all validation activities related to manufacturing processes for our portfolio of orthopedic implants. Reporting directly to the Senior Director of QA/RA, this role will collaborate closely with Manufacturing Engineering, Quality Assurance, R&D, and external partners to ensure all manufacturing processes comply with applicable regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485) and industry best practices. You will develop and oversee validation strategies, author and review validation documentation (IQ/OQ/PQ), conduct statistical data analysis, and drive continuous improvements, playing an essential part in ensuring our knee, hip, spine, and trauma products meet stringent quality and reliability standards.
Schedule: Monday to Friday
Location: Onsite, Draper UT (Must live in Utah)
Primary Responsibilities
- Develop and implement robust validation strategies (IQ/OQ/PQ) for new and existing manufacturing processes, test methods, and equipment.
- Work with cross-functional teams to define validation requirements, timelines, and deliverables based on project objectives and regulatory guidance.
- Author, review, and approve validation protocols, test plans, and final reports for manufacturing processes, equipment, and test methods.
- Lead and/or support execution of validation activities, ensuring adherence to established protocols and documentation practices.
- Collect and analyze data from validation studies using appropriate statistical tools.
- Document findings in comprehensive reports, identifying trends, root causes of process variation, and opportunities for improvement.
- Conduct and maintain process-related risk assessments (pFMEA, FTA), ensuring that identified risks are mitigated or controlled according to regulatory standards (ISO 14971).
- Partner with design teams to ensure alignment between product risk profiles and validated process controls.
- Identify, recommend, and implement process improvements and best practices to enhance manufacturing efficiency, product quality, and compliance.
- Engage with Lean or Six Sigma principles to drive data-based improvements and reduce process variability.
- Ensure all validation activities and documentation meet relevant regulatory requirements (FDA, ISO 13485) and industry standards.
- Participate in internal and external audits (FDA, Notified Bodies) by serving as a subject matter expert on validation processes and documentation.
- Collaborate with Manufacturing Engineering, QA, R&D, and Regulatory Affairs to support new product introductions, design changes, and process transfers.
- Provide validation expertise and guidance, mentoring junior engineers and other team members on best practices in process validation.
- Work with suppliers to ensure their processes and equipment used for manufacturing critical components are adequately validated.
- Oversee and review supplier validation documentation, driving alignment with internal quality standards and regulatory expectations.
- Perform other job-related duties as assigned.
Training and Experience
- Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, or related field) or a relevant scientific discipline required.
- 7 years of experience in process validation, manufacturing, or quality engineering within the medical device industry, ideally involving orthopedic implants (knee, hip, spine, trauma).
- ASQ certification a plus (CQE, CSSBB, CRE).
- Proficient in the use of statistical software tools (e.g., Minitab) for data analysis (ANOVA, DOE, capability studies).
- Strong knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and other relevant standards (ISO 14971, ISO 14644).
- Demonstrated expertise in process validation principles (IQ/OQ/PQ), protocol writing, and statistical analysis (e.g., Minitab).
- Familiarity with risk management tools (pFMEA, FTA) and methodologies (Six Sigma, Lean) is a plus.
- Experience with GMP/GLP practices, equipment qualification, and test method validation.
- Excellent written and verbal communication skills for preparing technical documentation and collaborating with cross-functional teams.
- Strong analytical problem-solving abilities and attention to detail.
- Ability to prioritize tasks effectively in a fast-paced, regulated environment.
Benefits:
We offer competitive compensation and excellent benefits including:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discounts
- Flexible spending account
- Health insurance
- Life insurance
- Paid Holidays
- Paid time off
- Parental leave
- Tuition reimbursement
- Vision insurance
- Wellness incentives
- UTA Transit Pass
