Position – Engineer (New Product Development)
Work requires independent evaluation, selection and application of standard engineering techniques, procedures, and criteria, using judgment and ingenuity in making minor adaptations and modifications. Assignments include disposables design and development, tests of materials or products, preparation of specifications, process study, research investigations, report preparation and other activities of limited scope. Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, and company practices and policies.
- Performs testing per test method or protocol – asks questions, seeks to understand, highlights failures as soon as they arise and can help trouble shoot if there are issues with the test method or set up.
- Helps to develop new test methods and improve existing methods
- Works across multiple quality systems.
- Responsible for detailed documentation for product testing and specifications.
- Understanding of BCT risk management procedures and concepts, able to apply appropriate statistical rationale to test protocols to reflect previously determined design element risks.
- Participates or manages projects or portions of project that could include development of project scope and estimates, initiation of requests for capital when required, specification of equipment and installation requirements, management of costs to budget, and support of IQ/OQ and final documentation in accordance with acceptable engineering practices.
- Conducts studies and makes recommendations for the use or changes to parts, components, or sets.
- Prepares and reviews engineering/technical documents such as reports, SOP’s, protocols, schedules and budgets, and vendor provided documents and drawings.
- Ensures that process and equipment designs are compliant with all Company policies and procedures as well as all Local, State, and Federal directives, laws and regulations.
- Provides work direction to engineering support staff (manufacturing, technicians).
- Takes initiative and demonstrates inquisitive approaches to solve moderately complex problems, identifying problems, generating alternatives and recommending solutions.
- Follows department processes and regularly makes recommendations on these processes.
- Follows technical specification requirements, developing reports, charts and graphs to support project recommendations and responds to questions from technical staff members and management.
- Works cooperatively and effectively in a team environment or across teams to achieve common goals and results.
- Analyzes data and presents it in appropriate forums.
Education – Graduate Degree in Engineering (Mechanical, Biomedical, Polymer)
- Minimum 2-3 years experience.
- Prefer experience in the medical device industry or highly regulated industry.