About Elevaris Medical Devices
Tired of working at a "good" job?
At Elevaris, our goal is not to be good, it's to be extraordinary.
Extraordinary performance comes from extraordinary people. And the foundation for extraordinary people is extraordinary culture. Our values describe the behaviors that define our unique culture. They are what set us apart and what makes us trusted leaders in our field.
Elevaris Medical Devices is leveraging a legacy of trust and expertise to usher in a new era of precision medical device development and manufacturing capabilities. We are development and engineering experts focused on delivering precision solutions to our medical device customers. Elevaris Medical Devices is one of the world's leading manufacturers of made-to-spec procedural needles. Beyond needles, we are also a Contract Development and Manufacturing Organization (CDMO) to industry-leading, multi-national healthcare companies, global original equipment manufacturers (OEMs), and emerging technology companies. We also distribute a wide range of complementary pharmaceutical products, surgical instruments, and medical supplies.
About the role
The Sustaining Engineer supports released medical devices across their full product lifecycle to ensure ongoing safety, quality, and regulatory compliance. This role emphasizes product sustaining activities, including compliance assessments and remediation efforts. The Sustaining Engineer leads cross-functional collaboration with design, compliance, manufacturing, and post-market teams to support products currently on the market.
What you'll do
- Develop and implement robust design procedures, processes and systems to ensure product sustainability and reliability that comply to US FDA and EU MDR requirements
- Investigate product compliance status, identify gaps, remediate gaps by conducting tests to evaluate compliance
- Lead the effort to bring existing designs and design history files to current meet current regulatory requirements
- Collect and analyze data to monitor product performance by evaluating the nonconformances, complaints, and field issues in compliance with FDA and ISO 13485 requirements
- Function as an independent contributor to plan, schedule, and perform tasks
- Perform root cause analysis and support Corrective and Preventive Actions (CAPA)
- Execute and document verification and validation activities per design control requirements
- Prepare and issue Engineering Change Orders (ECOs) for changes to released medical devices
- Collaborate with Quality, Regulatory, Manufacturing, Supply Chain, and Customer Support teams
- Ensure technical documentation is accurate, complete, and audit-ready
- Upholds and role-models company Values of Integrity, Invested, Inclusion and Ingenuity
- Other duties as assigned by management
Qualifications
MINIMUM REQUIREMENTS:
- Bachelor’s degree in engineering (Mechanical, Biomedical, or related field)
- 3–6 years of engineering experience in a regulated industry, preferably medical device
- Working knowledge of FDA QSR, ISO 13485, EU MDR requirements and design controls
- Experience with CAD software (AutoCAD, SolidWorks) and other engineering and statistical tools
- Experience with structured problem-solving tools (e.g., 5 Whys, Fishbone, FMEA)
PREFERRED SKILLSET:
- Project planning skills and collaboration to plan, schedule, and perform tasks.
- Ability to work effectively in a fast-paced and constantly evolving environment
- Strong documentation, analytical, and communication skills
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