Sr. Packaging Engineer
Proclinical is currently recruiting for a Senior Packaging Engineer with a leading medical technology company located in Orange County, CA. As the Senior Packaging Engineer, you will be responsible for the development of packaging components and systems for Class III Medical Device.
- Conceive, design and develop packaging components and systems of moderate complexity for medical device and/or delivery systems in accordance with quality system requirements and with moderate supervision.
- Design, order and procure components.
- Conduct engineering analysis and feasibility testing of packaging components/systems to ensure proper fit and function.
- Partner with Quality and Regulatory to conduct risk analysis and develop/execute design verification and validation activities to relevant packaging standards.
- Partner with Manufacturing to develop assembly procedures.
Skills and Requirements:
- BS in Mechanical/Industrial Engineering (or equivalent).
- Minimum of 3 years of experience in Medical Device packaging is required.
- Knowledge of Medical Device Packaging standards for heart valves and delivery systems (i.e. ASTM D642, D999, D3951, D4169, D4332, D4728, D4991, D5276, D6344, D6653, F88/F88M, F1886, F1929, F1980, F2096, ISO 11607-1/-2)
- Knowledge of the product development process and applicable Quality System requirements in the medical device industry is required.
- Must be able to work effectively and collaborate within cross functional teams.
- Must be able to effectively communicate (verbally and in writing) test results, analysis and conclusions to technical/nontechnical personnel.
- Must have strong documentation skills.
- Must take initiative and have the ability to conduct hands-on work.
- Must possess the ability to handle tasks with high attention to detail.
If you are having difficulty in applying or if you have any questions, please contact Ken Cadima at (+1) 415-660-4945 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.