Crest Solutions are seeking a Senior Packaging Engineer to join our team. The ideal candidate will be responsible for managing various packaging projects, including the designing, developing, and validating a wide variety of package designs to support the development of orthopedic implants and associated devices that are of a complex nature. He or she will also be responsible for developing and coordinating the requirements and specifications for new packaging equipment and processes. Experience with new technologies that will drive packaging innovation resulting in competitive advantages across global platforms is desired.
Principal Duties and Responsibilities
- Leads the design of new packages and improvement of legacy designs and manufacturing processes or serve as a key member on a project teams.
- Review and understand equipment specifications as supplied by equipment vendors. Management of capital projects from feasibility concept through installation and validation.
- Directs the generation of prototype samples to evaluate new materials and/or design concepts.
- Leads the Risk Analysis role for the package design, process design and process FMEA’s.
- Develops comprehensive validation plans generates protocol and reports.
- Manages collaboration across multiple international facilities.
- Identifies new technologies that will provide innovation and product differentiation.
- Support and manage as required Packaging Development related quality improvement initiatives.
- Coordination of internal and external/contractor resources to develop solutions required to solve complex engineering problems will be a primary focus
- Strong communication, teamwork and organizational skills are essential.
- A thorough understanding of ISO13485, ISO11607, 21 CFR 820 and Process Validation is a must.
- An ability to manage multiple projects.
- 3 - 5 years' experience in a Medical Device or other regulated industry
- Conducting feasibility studies to estimate product cost as well as analyze capital equipment, capacity, and capability requirements;
- Executing equipment qualification and process validation projects
- Developing and executing project plans and scheduling
- Programming and troubleshooting processes and standards;
- Working with rapid prototyping technologies.
- Strong project management skills
Education/ Experience Requirements
- Must have a Bachelor’s degree or equivalent in Engineering or a related field, plus 3 years of experience in a manufacturing environment.
- Maternity/Paternity Paid Leave
- Work From Home
- Paid Holidays
- Employee Events
- Performance bonus
- Flexible Schedules
- Life Insurance
- Professional Development