Senior Medical Device R&D Engineer: Integration & Quality

Lancesoft; Plymouth (MN); On-site; USD 110,000 - 140,000; Full time

Job summary

Lancesoft has an opening for a Senior R&D Engineer in Plymouth, MN, focusing on integration of an acquisition into a new quality system. The role involves transferring specifications, validating test methods, and ensuring alignment with regulatory and manufacturing needs.

It requires strong design control experience and the ability to collaborate across quality, manufacturing, and regulatory teams. The position emphasizes documentation accuracy, release of updated inputs/outputs, and potential

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, Electrical, or related field with ≥4 years of relevant experience.
• 12.

Responsibilities

• Review and transfer specifications into the new quality system.
• Update design inputs and outputs and release in the new system.
• Collaborate with Quality, Manufacturing, and Regulatory teams to meet requirements.
• Develop and document verification and validation protocols as needed for method transfer.
• Review engineering drawings, test protocols, and reports to ensure compliance with quality standards.

Skills

Test method validation

Equipment qualification

Regulatory requirements

Verification and validation testing

Statistical methods

Statistical tools

Education

Bachelor’s degree in Mechanical, Biomedical, Electrical, or related field

Master’s degree in Mechanical, Biomedical, Electrical, or related field

Tools

Electronic documentation system

Job description

Lancesoft has an opening for a Senior R&D Engineer in Plymouth, MN, focusing on integration of an acquisition into a new quality system. The role involves transferring specifications, validating test methods, and ensuring alignment with regulatory and manufacturing needs.

It requires strong design control experience and the ability to collaborate across quality, manufacturing, and regulatory teams. The position emphasizes documentation accuracy, release of updated inputs/outputs, and potential