Ensure the establishment and execution of world-class design & validation control processes that deliver safe and reliable products, while also enabling speed to market. You will partner with product development teams to ensure safety and efficacy is demonstrated. At all times throughout the process, you will identify and help mitigate risks.
ESSENTIAL JOB FUNCTIONS:
- Drive Design Assurance support and oversight for product development activities
- Ensure product development team(s) follow critical procedures & validation processes
- Ensure risk management tools are employed and evolving (HARA, DFMEA, PFMEA). Oversee and ensure risk assessments adequately address safety and efficacy and are compliant to the highest standards. Promote a "safe culture"
- Ensure requirements traceability and flow from customer requirements into L1/L2 specs
- Ensure validation targets, pass/fail criteria & procedures exist and are adhered too
- Establish standard work for validation & verification process assessments & adherence
- Ensure compilation, storage & reuse of critical validation history documentation
- Ensure robust, proactive validation reviews by leveraging standard work & best practices
- Ensure post sales assessments are conducted & lessons learned part of future programs
- Perform independent assessments of new product development programs
- Review and approve critical design & validation process milestones
SKILLS & KNOWLEDGE:
- BS Degree in Mechanical or ElectricalEngineering or equivalent. MSdegreepreferred
- Minimum 12years of experience in product validation and/or product quality
- Strong acumen for industry best practices in development, testing & manufacturing
- Experience in establishing and implementing quality metrics for product development
- Extensive use of the Microsoft Office suite. Experienced with PPT & Excel
- Strong communications skills, problem-solving & ability to influence required
- Engineering and office environment conditions.
- Infrequent travel on occasion and according to needs of business as project(s) dictate