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.