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Engineer I, Device Development (Laboratory)
100 College Street New Haven, CT 06510 US
Job Description
This is what you will do:
This position will serve the role of Engineer I for device development of company products including continuous product improvement within the Development function. The candidate will support technical design and development activities for device and combination products and assist the technology transfer.
You will be responsible for:
- Manage medical device test method and specification development, including test method development, validation, transfer, and life cycle management.
- Support the laboratory operation such as sample inventory, equipment qualification and maintenance.
- Conduct characterization for device function, assembly, manufacturability, etc. using both CAE and traditional engineering techniques.
- Test mechanical or electromechanical systems on bench top models or production representative units, during design development and verification.
- Consult with third parties such as specialist manufacturers and toolmakers.
- Communicate effectively, both verbally and in writing, internally across departments and with external suppliers.
- Comply with the Company’s quality assurance requirements as well as applicable regulatory requirements.
- Experience in design control activities.
- Knowledge of primary containers and drug delivery.
- Understanding of mold, fixture design and build as well as application of validation processes (IQ/OQ/PQ).
- Interface with the medical device vendor and tooling company.
- Knowledge of the regulatory and compliance requirements of device design controls and combination products (i.e. FDA QSR 21 CFR Part 4 and 820/ISO13485 quality system requirements).
- The duties of this role are conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15-30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/de-gown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
- Bachelor’s degree in Engineering (Biomedical, Chemical, Mechanical, or Electrical Engineering) plus 1 to 3 year experience in laboratory. Experience with injector based combination product preferred.
Appendix B: Physical and Mental Requirements
- [For lab-based positions:] The duties of this role are conducted in an lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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