R&D Engineer

Grove Technical Resources; Minnesota; On-site; USD 110,000 - 140,000; Full time

Job summary

Grove Technical Resources seeks a Senior R&D Engineer to drive medical device R&D efforts, design controls, and V&V in an integration project. You will transfer specifications, validated test methods, and design documentation into a new PLM and quality system, ensuring regulatory and manufacturing compliance.

The role emphasizes cross-functional collaboration with Quality, Manufacturing, Regulatory, and engineering teams, plus execution of validation activities and documentation control in a

Qualifications

• Bachelor's degree in Mechanical, Biomedical, Electrical Engineering, or a related field with at least 4 years of relevant experience.
• OR Master's degree in a related engineering field with at least 2 years of relevant experience.
• Preferred 5–10 years of R&D Engineering experience, ideally within the medical device industry.
• Strong analytical, problem-solving, communication, and cross-functional collaboration skills.

Responsibilities

• Review and transfer existing engineering specifications into a new Product Lifecycle Management (PLM) system.
• Review and update design inputs and outputs to ensure alignment with product requirements.
• Transfer validated test methods into a new quality system, identify documentation gaps, and update procedures as needed.
• Support test method validation, equipment qualification, and verification and validation activities.
• Review engineering drawings, test protocols, reports, and technical documentation for regulatory and quality compliance.
• Develop, execute, and document verification and validation protocols when required.
• Collaborate with Quality, Manufacturing, Regulatory, and cross-functional engineering teams.
• Support challenge testing, misuse testing, process validation, and Use Failure Mode and Effects Analysis (UFMEA), as needed.
• Ensure all documentation is properly updated and released within electronic document management systems.

Skills

Medical Device R&D Engineering

Medical Device Design Controls

Design Inputs and Outputs

Test Method Validation

Verification & Validation (V&V)

Process Validation

Equipment Qualification

Product Development Process (PDP)

PLM / Document Management Systems

Regulatory and Quality Compliance

Education

Bachelor's degree in Mechanical, Biomedical, Electrical Engineering, or related field

Master's degree in related engineering field

Job description

We are looking for an experienced Senior R&D Engineer to support a medical device acquisition integration project. The ideal candidate will have strong experience in medical device R&D, design controls, test method validation, and verification and validation (V&V).

This role will focus on transferring engineering specifications, validated test methods, and design documentation into a new quality management system while ensuring compliance with regulatory, quality, and manufacturing requirements.

Key Responsibilities:

• Review and transfer existing engineering specifications into a new Product Lifecycle Management (PLM) system.
• Review and update design inputs and outputs to ensure alignment with product requirements.
• Transfer validated test methods into a new quality system, identify documentation gaps, and update procedures as needed.
• Support test method validation, equipment qualification, and verification and validation activities.
• Review engineering drawings, test protocols, reports, and technical documentation for regulatory and quality compliance.
• Develop, execute, and document verification and validation protocols when required.
• Collaborate with Quality, Manufacturing, Regulatory, and cross-functional engineering teams.
• Support challenge testing, misuse testing, process validation, and Use Failure Mode and Effects Analysis (UFMEA), as needed.
• Ensure all documentation is properly updated and released within electronic document management systems.

Required Technical Skills:

• Medical Device R&D Engineering
• Medical Device Design Controls
• Design Inputs and Outputs
• Test Method Validation
• Verification & Validation (V&V)
• Process Validation
• Equipment Qualification
• Product Development Process (PDP)
• PLM / Document Management Systems
• Regulatory and Quality Compliance

Qualifications:

• Bachelor's degree in Mechanical, Biomedical, Electrical Engineering, or a related field with at least 4 years of relevant experience.
• OR Master's degree in a related engineering field with at least 2 years of relevant experience.
• Preferred 5–10 years of R&D Engineering experience, ideally within the medical device industry.
• Strong analytical, problem-solving, communication, and cross-functional collaboration skills.