Responsibilities
- Lead end-to-end design controls for hardware and software development from initiation through closure.
- Develop and manage procedures for design and development in compliance with ISO 13485 §7.3, including templates for design plans, inputs/outputs, reviews, verification and validation, and DHF organization.
- Create a flexible design history file (DHF) framework that supports distributed teams and multi-site operations.
- Evaluate the impact of all design changes—including software updates, hardware or material modifications, packaging, and labeling—on documentation, traceability, verification, and validation requirements.
- Ensure all design changes follow formal change control processes within the QMS, with proper document control, record linkage, and training updates.
- Collaborate with Regulatory and Quality teams to identify regulatory implications of design changes and determine necessary additional testing or documentation.
- Integrate risk management practices across the product lifecycle.
- Execute risk management activities in line with ISO 14971, including hazard analysis, FMEAs, and linking risk controls to verification and traceability.
- Maintain up-to-date risk files that reflect current design decisions, review outcomes, and release statuses.
- Write and review verification and validation protocols and reports, covering hardware, material specifications, and packaging changes.
- Ensure software lifecycle documentation meets IEC 62304 standards where applicable.
- Define design transfer requirements to ensure smooth handoff from development to manufacturing, including traceability via BOMs, process validation, and release criteria.
- Organize and lead cross-functional design reviews across hardware, software, and materials teams, integrating risk, validation, and change documentation.
- Train internal teams on design control processes using practical tools like checklists and templates tailored to internal workflows.
- Act as the subject matter expert during external audits, representing design control practices to auditors such as BSI.
- Respond to audit findings related to design controls, identify gaps, and lead corrective actions to resolution.
- Manage the structure and maintenance of design evidence within the QMS (e.g., Dot Compliance), working closely with document control and quality systems teams.
Benefits
- Healthcare coverage
- Dental care benefits
- Mental health and wellness support
- Resources for parental planning
- Retirement savings plans
- Generous paid time off policy
Compensation
Not specified
Work Arrangement
Remote (Worldwide)
Team
Cross-functional teams including engineering, operations, manufacturing, product, and quality assurance
Other
Up to 20% domestic travel required
