The Senior Staff Compliance Engineer will assume various Compliance Engineering responsibilities including interface with third party test organizations, product and process standards compliance and standards evaluation for existing and new products and processes. Position supports all existing and proposed product lines including those in active development.
The Senior Staff Compliance Engineer works closely with Product and Process Development Engineers to prevent compliance issues by reviewing design data; identifying and resolving product and engineering design issues; identifying short-term and long-range issues; researching and identifying applicable regulatory and industry compliance standards and codes; developing compliance policies.
Essential Duties & Responsibilities:
Determines compliance by establishing compliance test standards; conducting and witnessing tests; performing diagnostic procedures; measuring performance; analyzing and evaluating findings; performing forensic analysis of failures; troubleshooting failures; supervising sub-contractors.
Develops compliance plans for IEC 60601-1 Type Testing, including:
- IEC 62304 Medical Device Sftware Life Cycle
- IEC 60601-1-11 ME Equipment in Hme Health Care Environment
- IEC 60601-1-2 ME Equipment Electrmagnetic Disturbances
- IEC 60601-1-8 Alarm Systems in ME equipment
by researching, analyzing, selecting, and applying compliance engineering concepts, approaches, techniques, and criteria; adapting and modifying compliance engineering options; developing and evaluating new compliance methodologies; qualifying vendors, components, and parts.
- May supervise and administer specific aspects of the quality system.
- Tracks, assesses, and manages testing and implementation of changes to domestic and international standards, regulations and guidance documents that the company must comply with.
- Global database administrator of commercially applicable standards and serves as primary contact with the vendor.
- Develops company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations.
- Leads or participates in internal audits, supplier audits to ensure systems comply with requirements and are effective.
- Participates as member of the design team. Activities may include assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs.
- Leads risk management, validation, sample size, and external standards review and implementation activities.
- Leads implementation of techniques like six sigma, lean manufacturing and Total Quality Management to improve Dexcom operations.
- Takes the initiative to develop systems and processes that improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs.
- Applies proficient computer skills in the use of Microsoft Office and database applications (e.g. Excel and MiniTab).
- Assumes and performs other duties as assigned.
- Optional section - remove if not used.
- Add additional qualifications preferred, such as certifications, industry experience, etc.
Experience and Education Requirements:
- Typically requires a Bachelor's degree in a technical discipline, and a minimum of 13+ years related experience or a Master's degree and 8+ years equivalent industry experience of a PhD and 5+ years of experience.
- Possesses expert knowledge of leading technical areas.
- May be externally recognized as an expert in technical field.