Vacancy expired!
Piper Companies is seeking an Associate Engineer in King of Prussia, PA to join a medical device company.
This position is primarily responsible for the remediation of Design History Files for all company products. This is a critical position within the Engineering team to provide documentation support in the design, development and continuous improvement of our products. Will start out as a 6 month contract with potential for extension or conversion. Responsibilities:- Review product requirements for traceability and risk remediation.
- Review Design and Development procedures and identify optimal improvements.
- Responsible for the creation and update of the Design History Files documentation.
- Perform gap analyses for Design History Files.
- Develop timelines, tracking and reporting tools for project progress.
- Develop accurate technical reports and documenting test results for various stakeholders and for inclusion in the Design History File.
- Review verification and validation deliverables for compliance with regulatory requirements.
- Update product CAD models and drawings.
- May draft protocols and lead execution of testing for mechanical testing.
- Participate in risk management activities (e.g. dFMEA, pFMEA) and lead design activities such as Design Input, Design Output, Design Verification, Design Validation, and Design Transfer (Ex. Mechanical Testing, Cadaver Lab, etc.)
- 3+ years experience in medical devices.
- Strong knowledge of Design Controls and Design History Files.
- Experience working per ISO 13485 and 21 CFR Part 820, specifically as the manufacturer of record of implantable devices preferred.
- Experience in modeling and drafting in CAD, Creo preferred.
- Experience in principles and applications of GD&T.
- General knowledge of medical materials, specifically implantable materials
- Experience developing complex orthopedic and spine surgical systems desired
- Bachelor's degree in Engineering, Mechanical Engineering preferred.
- Self-starter, proactive, and accountable individual able to motivate self and others.
- Must possess strong work ethics.
- Able to work independently with minimal supervision.
- Excellent verbal and written communication skills.
- Strong organizational and time-management skills.
- Excellent mechanical/mechanism design aptitudes, and problem solving/analytical skills.
- Ability to create procedures, work instructions, and forms to ensure compliance with regulatory requirements.
- Ability to effectively manage multiple conflicting priorities in fast-paced environment.
- Ability to learn and absorb product knowledge quickly and efficiently.
Vacancy expired!