Sr R/D Engineer

Position Overview

We are seeking a highly skilled and motivated Senior R&D Engineer to join our team to help with integration of acquisition. In this critical work, you will play a leading role in reviewing and transferring specifications into our PLM system, working to bring test methods into our quality system, reviewing and updating design inputs and outputs. This position may also be involved in challenge testing, misuse testing, process validation and/or UFMEA input or writing. This is a unique opportunity to contribute to a project team that has a defined role and timeline - making sure that regulatory, quality, manufacturing and product requirements are met while integrating into a new quality system.

Key Responsibilities

• Specification Transfer: Review current released specifications and release in new quality system. Review design inputs and outputs to verify if updates are needed.
• Test Method Transfer: Review current validated test methods at one location and transfer to a new quality system. Upon transfer, update (if needed) and validate. This work requires documentation review, understanding procedures, identifying gaps/differences, updating methods and release in an electronic documentation system.
• Design input and Output: Review current design inputs and compare against design outputs. Update (if needed) without need of repeating verification and/or validation testing. Release in new quality system.
• Cross-Functional Collaboration: Work closely with Quality, Manufacturing, and Regulatory teams to ensure that all requirements and quality standards and business needs are being met.
• Verification & Validation: Support efforts to develop, execute, and document verification and validation protocols (if needed by transfer of test methods to new location).
• Documentation: Review technical documentation, including engineering drawings, test protocols, and reports, to ensure compliance with the company’s quality systems and regulatory standards. Update and release new documentation in electronic documentation system ensuring good documentation practices.

Desired Technical Expertise:

• • Proficiency in test method validation, equipment qualification.
  • Strong understanding of medical device design controls, PDP processes, and regulatory requirements.
  • Experience with verification and validation testing, including familiarity with statistical methods and tools.

    Soft Skills:

  • Excellent communication and collaboration abilities.
  • Proven leadership skills, with the ability to influence and drive results in a cross-functional team environment.
  • Strong problem-solving and analytical skills.

Travel: Travel may be required: < 10%

Minimum Qualifications

• Bachelor’s degree (Mechanical, Biomedical, Electrical, or related field) and a minimum of 4 years of relevant experience
• Master’s degree (Mechanical, Biomedical, Electrical, or related field) and a minimum of 2 years of relevant experience.

Preferred Qualifications:

• Experience: Minimum of 5-10 years of experience in R&D engineering, preferably in the medical device industry.