Senior Research And Development Engineer

Genesee BioMedical, Inc.; Denver (CO); On-site; USD 120,000 - 160,000; Full time

Job summary

Genesee BioMedical, Inc. seeks an experienced R&D Engineer to lead the full product lifecycle for medical devices, from concept through design, verification, and validation, while sustaining legacy products in the field.

This senior role requires strong engineering judgment, deep regulatory knowledge, and the ability to resolve complex problems across new and existing product lines.

Qualifications

• 7+ years of experience in medical device R&D, including root cause analysis and CAPA resolution.
• Strong understanding of design controls, product development lifecycle, and regulatory requirements (FDA/ISO 13485).
• Proficiency in CAD software (SolidWorks) and risk management tools (FMEA).
• Experience mentoring or providing technical leadership to junior engineers.

Responsibilities

• Lead full product lifecycle for new medical devices from concept to design, verification, and validation.
• Sustain legacy products in the field and resolve complex design issues and CAPAs.
• Collaborate with Production, Quality, and Supply Chain on obsolescence and manufacturability.
• Ensure compliance with GMP, ISO 13485, and FDA regulations; mentor junior engineers.

Skills

Problem solving

Analytical thinking

Communication

Leadership

Mentoring

Education

Bachelor's degree in Biomedical Engineering

Bachelor's degree in Mechanical Engineering

Advanced degree preferred

Tools

SolidWorks

AutoCAD

Creo

FMEA

Job description

The R&D Engineer leads the full product lifecycle for new medical devices, from concept and feasibility through design, verification, and validation, while applying senior-level expertise to troubleshoot and sustain legacy products in the field. This role requires strong engineering judgment, deep regulatory knowledge, and the ability to resolve complex problems across new and existing product lines.

Duties and responsibilities:

Concept Generation & Feasibility:

• Research clinical needs, market trends, and the competitive landscape; generate innovative concepts and lead feasibility studies and prototyping to assess viability.
• Partner with clinicians, marketing, and business development to define product requirements and specifications.

Design & Development:

• Translate design inputs into detailed engineering designs, specifications, and drawings using CAD software (e.g., SolidWorks, AutoCAD, Creo).
• Select materials and manufacturing processes considering biocompatibility, sterilization, and cost; own design documentation, including Design History Files (DHF).

Verification & Validation:

• Develop and execute test plans for design verification and validation (e.g., performance, durability, biocompatibility); analyze results and prepare engineering reports.
• Independently resolve complex design issues and non-conformances; support usability studies and clinical trials as needed.
• Serve as a senior technical resource for fielded/legacy products, leading root cause analysis and corrective/preventive actions (CAPAs).
• Evaluate and implement design or process changes to extend product life, improve reliability, or reduce cost; partner with Production, Quality, and Supply Chain on obsolescence and manufacturability issues.

Regulatory, Compliance & Leadership:

• Ensure all R&D and sustaining activities comply with GMP, ISO 13485, and FDA regulations (21 CFR Part 820/807); lead risk management activities (e.g., FMEA, PHA).
• Manage project tasks, timelines, and deliverables across new development and legacy sustaining work; mentor junior and mid-level engineers.

Qualifications:

Education:

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a closely related engineering field; advanced degree a plus.

Experience:

• 7+ years of experience in medical device R&D, including root cause analysis, CAPA resolution, and other legacy/sustaining engineering work.
• Strong understanding of design controls, product development lifecycle, and FDA/ISO 13485 regulatory requirements; proficiency in CAD software (e.g., SolidWorks) and risk management tools (e.g., FMEA).
• Experience mentoring or providing technical leadership to junior engineers preferred.
• Experience machining parts on CNC and / or lathe

Skills:

• Excellent problem-solving, analytical, and communication skills; able to lead cross-functional teams and mentor engineers independently.
• High attention to detail and commitment to quality and patient safety, balancing new development priorities with ongoing legacy product support.