Sr. R&D Engineer

Providence Medical Technology, Inc.; Pleasanton (CA); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Stock Options

Job summary

A medical device company is seeking a Sr. R&D Engineer in Pleasanton, CA. The role involves leading research and development for spinal instruments and implants, driving innovation from concept to commercialization. Candidates should possess at least 7 years of R&D experience within the medical device industry, with a keen focus on orthopedic products. This position requires strong mechanical design skills, project management expertise, and the ability to collaborate effectively with cross-functional teams to achieve optimal outcomes.

Qualifications

• 7+ years of experience in R&D within the medical device industry focusing on orthopedic products.
• Proven track record of bringing medical devices from concept to market.
• Deep understanding of anatomy and biomechanics related to spine.

Responsibilities

• Lead research and development efforts to create original spinal instrumentation and implants.
• Manage R&D projects, including timelines and budgets.
• Collaborate cross-functionally with regulatory and clinical teams.

Skills

Technical writing

Communication skills

Knowledge of materials

CAD proficiency (SolidWorks)

Mechanical design experience

Education

Bachelor’s degree in Biomedical Engineering

Bachelor’s degree in Mechanical Engineering

Tools

SolidWorks

FEA software

Job description

Benefits include: Medical, Dental, and Vision Insurance, 401(k), Stock Options

NOTE: You must have 7+ years experience in R&D within the medical device industry, with a strong focus on orthopedic products to be considered for this position.

Providence Medical Technology, Inc. is a privately‑held medical device company focused on innovation solutions for cervical spine conditions. The company has pioneered a proprietary approach to posterior cervical fusion and has developed surgical instrumentation and implants that offer unique benefits to the $2 billion worldwide cervical spine market.

Our purpose is to improve clinical outcomes for high‑risk patients and prevent surgical failures of the cervical spine.

LOCATION

We are currently hiring for this position in Pleasanton, CA.

SUMMARY

• The Sr. R&D Engineer will lead research and development efforts to develop original instrumentation and implants to solve complex spinal disorders. The Sr. R&D Engineer will bring a strong background in medical device development, project management, design controls and regulatory compliance. This role requires strategic thinking, hands‑on engineering expertise, and the ability to drive innovation from concept through commercialization.

MAIN RESPONSIBILITIES:

• Drive new product development initiatives of orthopedic implants and instruments from ideation through design transfer and commercialization.
• Serve as technical lead and manage R&D projects including timelines, budgets, and resources allocations.
• Collaborate cross‑functionally with Regulatory, Quality, Marketing, Manufacturing, and Clinical teams to ensure project success.
• Collaborate with Product Marketing and surgeons to identify unmet needs, refine design concepts, and evaluate usability.
• Conduct cadaver labs for surgical technique development of novel instruments and implants.
• Oversee prototype development using in‑house and external manufacturing resources.
• Create 3D CAD models, engineering drawings, and design specifications in compliance with industry standards (e.g., ASME Y14.5).
• Coordinate activities with vendors and consultants to ensure delivery of supplies and/or services needed to meet scheduled timelines.
• Ensure compliance with FDA, ISO 13485, and other applicable regulatory and quality system requirements.
• Oversee creation and maintenance of design history files, risk mitigation documentation and strategies, and verification/validation plans.
• Draft intellectual property as required to strengthen patent portfolio.
• Foster a culture of innovation, continuous improvement, and technical excellence within the team.

QUALIFICATIONS:

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or related field.
• Minimum of 7 years of experience in R&D within the medical device industry, with a strong focus on orthopedic products.
• Proven track record of bringing medical devices from concept to market.
• Deep understanding of anatomy, biomechanics, and clinical applications related to spine.
• Strong mechanical design experience developing instrumentation and implants, disposable single‑use instrumentation experience highly desired.
• Project management experience leading cross‑functional teams, with strong design control experience following FDA guidelines.

REQUIRED SKILLS AND ABILITIES:

• Good technical writing and communication skills.
• Knowledgeable in materials, including: Stainless steel, titanium, and plastic resins.
• Knowledgeable in component fabrication processes, including: Machining, wire EDM, laser cutting/welding, injection molding, and additive manufacturing.
• Proficient in CAD tools (e.g., SolidWorks), FEA, and other engineering software.

Our Mission is to establish Circumferential Cervical Fusion (CCF) as the standard of care for high‑risk patients.