The ideal candidate will have a solid background in system design and product development, with direct experience in regulatory compliance and documentation.
You'll play a key role in refining existing product documentation and ensuring continued regulatory alignment as part of an accelerated product remediation and continuous improvement initiative.
This role is part of a cross-functional design and service transfer project focused on improving the serviceability and reliability of robotic-assisted surgical systems. The project involves:
Updating Design History File (DHF) documentation
Defining servicing design inputs
Creating job cards and spare part technical specifications
Supporting servicing verification and validation activities
The candidate will work closely with R&D, Service Engineering, Quality, Operations, and Field Service teams to ensure design outputs are properly translated into production and servicing specifications in compliance with applicable regulatory frameworks.
The work is delivered in an agile environment with iterative planning cycles, backlog grooming, and regular cross-functional alignment.
Candidates must have experience with:
Software as a Medical Device (SaMD) concepts
Robotic or electromechanical medical device platforms
Skills Requirements:
5+ years of experience in system design and/or product development within the medical device industry
Strong experience in system design in a multidisciplinary organization, preferably involving robotic or electromechanical medical devices
Experience drafting and maintaining DHF (Design History File) content, including:
User needs
System requirements
Design inputs
Traceability matrices
Risk documentation
Ability to define servicing design inputs and translate them into:
Job cards
Spare part replacement procedures
Planned maintenance instructions
Troubleshooting guides
Installation instructions
Spare part technical specifications
Experience with design transfer and/or service transfer processes
Ability to support risk analysis (uFMEA, etc.) and usability planning
Familiarity with ISO 14971 (required)
Familiarity with IEC 62366 (preferred)
Ability to define testable requirements and support V&V protocol development
Experience with traceability management
Additional Requirements:
Reliability analysis experience, including:
Mean Time to Failure (MTTF)
Impact analysis for serviceable components
Worst-case servicing condition validation
Knowledge of:
21 CFR 820 (Quality System Regulation)
ISO 13485
EU MDR
FDA guidance on remanufacturing/refurbishment of medical devices
Strong interpersonal and collaboration skills
Ability to build consensus across cross-functional teams
Ability to communicate technical concepts to both technical and non-technical audiences
Experience identifying and resolving cross-team dependencies
Hands-on Agile or hybrid Agile experience:
Sprint planning
Backlog grooming
Daily standups
Retrospectives
Experience with:
Codebeamer and/or JIRA
Requirements management
Traceability tools
Experience working in highly regulated environments
CAPA-driven improvement project experience
Strong analytical and decision-making skills
Experience working in multi-site, cross-functional organizations
Excellent written and verbal communication skills
Preferred Qualifications:
Experience with SSRS (System Service Specification Requirements) creation and verification
Familiarity with lifecycle testing methodologies for serviceable components and systems
Experience supporting spare parts forecasting, demand planning, or BOM management
Understanding of Field Change Order (FCO) processes
Experience with ServiceMax or similar field service management platforms
Experience with refurbishment or redeployment programs for capital medical equipment
Certified Scrum Master (CSM), SAFe Agilist, or equivalent Agile certification
Experience facilitating cross-functional workshops, design reviews, or sprint demos in regulated environments
Education Requirements:
Bachelor's degree in an engineering or science-related field
Preferred disciplines:
Biomedical Engineering
Mechanical Engineering
Systems Engineering
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 62.49/hr.
