Senior R&D Engineer: Med Device Quality Transfer

Planet Pharma Group; Plymouth (MN); Vor Ort; USD 110.000 - 140.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Test method validation

Equipment qualification

Design controls

Regulatory knowledge

V&V testing

Statistical methods

Cross-functional collaboration

Leadership

Problem solving

Ausbildung

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

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

Jobbeschreibung

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