Sr R/D Engineer

Planet Pharma Group; Plymouth (MN); On-site; USD 110,000 - 140,000; Full time

Job summary

Planet Pharma is seeking a Senior R&D Engineer to lead the integration of acquisitions, transferring specifications into our PLM system and bringing test methods into our quality system. You will review design inputs/outputs, support challenge/misuse testing, and collaborate with Quality, Manufacturing, and Regulatory teams to ensure compliance.

The role requires strong expertise in medical device design controls, V&V testing, and regulatory requirements, with a leadership mindset to drive

Qualifications

• Bachelor's degree in Mechanical, Biomedical, Electrical, or related field.
• Master's degree in the same field with 2+ years of relevant experience.
• 4+ years of relevant R&D experience with emphasis on medical devices (for non-master's track).
• Experience with transfer of specifications into PLM and document control.

Responsibilities

• Review and transfer specifications into the PLM system.
• Transfer and validate test methods in the new quality system.
• Review design inputs/outputs and update accordingly.
• Collaborate with Quality, Manufacturing, and Regulatory teams to meet requirements.
• Develop and document verification and validation protocols.
• Review and release technical documentation to comply with quality standards.

Skills

Test method validation

Equipment qualification

Design controls

Regulatory knowledge

V&V testing

Statistical methods

Cross-functional collaboration

Leadership

Problem solving

Education

Bachelor's degree in Mechanical/Biomedical/Electrical or related field

Master's degree in Mechanical/Biomedical/Electrical or related field

Job description

Position Overview

We are seeking a highly skilled and motivated Senior R&D Engineerto 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.