About the Company
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.
- Execute end-to-end, product verification, while working under minimal guidance of technical leaders.
- Support product Verification activities across all phases of the Medical Device lifecycle.
- 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.
- Participate 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.
- Analyze system testing requirements and develop comprehensive test plans and strategies to ensure thorough coverage of system functionalities and requirements while adhering to regulatory requirements and company policies, working under direct supervision.
- Execute verification activities with minimal oversight.
- Maintain high-quality documentation in alignment with Design Control and regulatory requirements.
- Conduct peer reviews of test plans, protocols cases, and reports to ensure completeness and accuracy.
- Support compliance assessments against applicable national and international standards.
- Collaborate closely with cross-functional teams (Systems, Hardware, Quality & Regulatory) to ensure complete verification activities.
- Ensure proper use of statistical analysis and automation tools to deliver timely outcomes.
- Participate in continuous improvement initiatives to enhance testing processes and methodologies, contributing to the overall efficiency and effectiveness of the testing team.
- Engage with stakeholders to communicate testing progress, escalate critical issues, and facilitate decision-making related to system testing activities.
You'll thrive in the role if
- Bachelors/Masters Degree in Electrical Engineering, Electronic Engineering, Mechanical Engineering or Biomedical Engineering.
- You've acquired a total of 8 years of experience with minimum 6 years of experience in medical device or other similar industry.
- Solid experience specific to product verification test plan/protocols, executing V&V activities, generating, and analyzing test reports.
- In-depth understanding of medical device product development, preferably Design Control experience with Class-III/Class-3 medical devices (FDA CFR Title 21, 820.30).
- 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.
- Experience in designing and assessing compliance to national/international standards.
- Strong technical writing/documentation skills for regulated medical device design environment, including requirements definition.
- 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
- Hands-on experience with LabVIEW/Minitab tools.
- AI-Powered test automation.
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.
Heartstream is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
