Environmental Engineer at Geosyntec managing compliance projects and mentoring professionals. Overseeing environmental audits and ensuring regulatory compliance in engineering consulting.
About the role
- Senior Compliance Engineer ensuring compliance with regulatory standards for medical devices at Insulet. Collaborating with cross-functional teams to support design, development, and lifecycle maintenance.
Responsibilities
- Serve as a key member of cross‑functional project teams, including electrical, software, mechanical, manufacturing, and quality engineering, to support design, development, launch readiness, and lifecycle maintenance.
- Interface with nationally recognized test laboratories (NRTLs) to obtain and maintain product certifications.
- Collaborate with R&D staff to ensure consistent understanding and application of relevant standards and regulatory requirements across engineering disciplines.
- Develop compliance plans tailored to the scope, risk, and intended use of each program.
- Determine applicable U.S. and international standards in collaboration with Systems Engineering Leads, Regulatory Affairs, and Quality.
- Maintain working knowledge of FDA guidance and global standards related to mobile device technologies in medical products.
- Interpret external standards and ensure ongoing compliance via reviews of product changes.
- Monitor changes to regulatory requirements and external standards, performing gap analyses and communicating impacts to internal stakeholders.
- Coordinate and support system-level testing against relevant external safety, software, EMC, usability, and wireless standards.
- Organize and manage third‑party lab testing, documentation, reports, and compliance activities.
- Ensure that components critical to product safety are certified and properly documented.
- Audit Support & Compliance Governance
- Support internal audit readiness activities and respond to certification body inquiries.
- Coordinate cross‑functional compliance activities, ensuring alignment with program timelines, deliverables, and quality system requirements.
- Provide guidance to senior and executive leadership on critical compliance matters impacting product development, certification, or market access.
Requirements
- Bachelor’s degree required (preferred field of study: Systems Engineering, Electrical Engineering, Mechanical Engineering, Computer Science, Biomedical Engineering, or related technical field); Master’s degree preferred.
- Minimum five (5) years of experience as a Systems or Compliance Engineer in a multidisciplinary medical device environment.
- Five (5)+ years leading compliance‑specific initiatives for regulated medical devices in U.S. and international markets.
- Proficiency with key medical device standards and regulations, including ISO 13485, ISO 14971, IEC 62304, IEC 60601, IEC 62366, 21 CFR 820.30, and EU MDR; knowledge of additional in‑country standards is a plus.
- Domain expertise in one or more engineering disciplines, preferably Electrical Engineering, with exposure to Mechanical, Quality, and Test Engineering.
- Demonstrated systems engineering skills including requirements management, design trade‑offs, hazard analysis, safety assessments, and risk management.
- Deep understanding of medical device and software compliance standards, and the ability to apply appropriate test strategies based on device design.
- Proven ability to work effectively under a Quality Management System (QMS) within cross‑functional teams across development, V&V, manufacturing, regulatory, marketing, clinical, and quality functions.
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Junior Consultant supporting security and compliance projects for SMEs in Germany. Collaborating on NIS2, ISO 27001, and TISAX with structured guidance and clear responsibilities.
Senior regulatory reporting specialist for investment bank, building MiFID II and EMIR reporting functions from ground up with senior stakeholders.
Director of Regulatory Affairs leading engagement in ERCOT and SPP wholesale markets. Managing regulatory strategies and influencing outcomes on market design and policy issues.
Senior Director providing strategic leadership for U.S. wholesale electricity markets. Managing teams and regulatory strategy to enhance utility - scale project development.
Apprentice Regulatory Compliance Officer supporting compliance for Yara's product registrations. Collaborating with internal teams and ensuring adherence to regulatory standards in the UK.
Regulatory Affairs Officer ensuring compliance for Yara's agricultural products. Supporting global product registrations and liaising with regulatory teams and suppliers.
Risk & Compliance Officer assisting in risk management and compliance within Arthur Cox LLP. Engaging with legal and business support to uphold regulatory standards and protect firm’s reputation.
Vice President leading Government, Regulatory and Public Affairs at Modivcare. Overseeing advocacy, lobbying, and strategic engagement with public policy stakeholders.
Compliance Advisor for Global Sanctions supporting Fidelity’s enterprise Global Sanctions program. Responsibilities include alert management, investigations, and technology support.