About Us
Heartstream is building on our 40+ year legacy of growth and innovation in emergency medical technology to continue passionately pursuing our mission of saving lives, lowering the cost of healthcare, and advancing the science of resuscitation while serving the public access AED, EMS, military, and hospital market segments. Heartstream includes leading brands and products like HeartStart AEDs, Intrepid and DFM100 monitor defibrillators, Tempus monitor and Tempus ALS systems, and Corsium and ECI informatics solutions.
Your Impact
We are looking for a passionate System Test Designer to join us as we strengthen our product portfolio, expand our services and solutions, and bring game-changing technology to market. This team member will be responsible for working collaboratively with a team of cross-functional engineers.
- Leading end‑to‑end product verification testing, while working with stakeholders.
- Define, document, and continuously improve verification tests, ensuring complete traceability to system requirements.
- Perform requirement‑based verification tests, analyze results, and ensure complete coverage and compliance.
- Contribute in design reviews and deliver verification plans, test protocols and test reports.
- Identify, analyze, and drive technical issues to resolution through hands‑on investigation and collaboration.
- Leading product verification through the phases of the Medical Device lifecycle.
- Providing technical support and leadership on a cross-functional team.
- Define, document, and continuously improve verification tests including conducting peer reviews and maintaining traceability to requirements.
- Perform verification tests and conduct analysis of the test results to ensure complete verification of the requirements.
- Identifying, analyzing, owning, and driving technical issues to resolution.
- Perform work with little to no supervision as department subject-matter expert.
- Leads and participates in design reviews, including reviews of design verification plans, reports, and test artifacts.
- Work with design teams to isolate design errata, perform failure analysis, and verify design fixes.
- Development and execution of validation test plans, test records and Test fixtures.
- Keeps abreast of new developments in all relevant technological domains.
- Advises on change requests for system and related products.
- Provides technical leadership to ensure overall product development success.
- Keeps abreast of new developments in all relevant technological domains.
- Contributes to technology roadmaps and other strategic related activities.
- Provides technical leadership to ensure overall product development success.
You'll thrive in the role if
- You've acquired a total of 12 years of experience with minimum 8 years of experience in medical device or other similar industry.
- Demonstrated knowledge of global quality and regulatory standards for medical devices including IEC 60601, ISO 13485, ISO 14971, ISO 10993, ISO 17664, ISO 17665, ISTA, IATA etc.
- Solid understanding of medical device product development, preferably Design Control experience with Class III medical devices. (FDA CFR Title 21, 820.30)
- Experience specific to leading product verification.
- Experience in assessing compliance to national/international standards.
- Strong technical writing/documentation skills for regulated medical device design environment, including requirements definition.
- Demonstrates strong results orientation: This position requires the proven ability to consistently meet and/or exceed goals. The successful candidate must be capable of making commitments, setting priorities, and delivering results on time and on budget.
- Proven ability to communicate in both verbal and written form to technical and non-technical customers, stakeholders, and various levels of management.
- Possess strategic agility/vision: Sees ahead clearly; can anticipate future concerns.
- Develops and maintains effective relationships and is capable of quickly earning trust and respect.
Required Skills
- Bachelor's degree in Electrical/Electronics/Mechanical/Biomedical Engineering or related field. Master's degree is preferred.
- You've acquired a total of 12 years of experience with minimum 8 years of experience in medical device or other similar industry.
- Demonstrated knowledge of global quality and regulatory standards for medical devices including IEC 60601, ISO 13485, ISO 14971, ISO 10993, ISO 17664, ISO 17665, ISTA, IATA etc
- Solid understanding of medical device product development, preferably Design Control experience with Class III medical devices. (FDA CFR Title 21, 820.30)
- Experience specific to leading product verification.
- Experience in assessing compliance to national/international standards.
- Strong technical writing/ documentation skills for regulated medical device design environment, including requirements definition
- Demonstrates strong results orientation: This position requires the proven ability to consistently meet and/or exceed goals. The successful candidate must be capable of making commitments, setting priorities, and delivering results on time and on budget.
- Proven ability to communicate in both verbal and written form to technical and non-technical customers, stakeholders, and various levels of management.
- Possess strategic agility/vision: Sees ahead clearly; can anticipate future concerns.
- Develops and maintains effective relationships and is capable of quickly earning trust and respect.
Preferred skills to have
- Hands-on experience with LabVIEW/Minitab tools.
- AI-Powered test automation.
- Certified Systems Engineering Professional (CSEP).
If you find this role intriguing and possess several of the required experiences, we welcome your application. You might still be the ideal candidate for this position or other openings at Heartstream.
Equal Opportunity Statement
Heartstream is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
