Website:
heartstream.com
Job details:
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 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 system engineering activities and product compliance to applicable standards while working under minimal guidance of technical leaders.
- Define, document, and continuously comply to requirement and ensuring complete traceability to system requirements.
- Identify, analyze, and drive technical issues to resolution through hands‑on investigation and collaboration.
- Assess regulatory standards and plan system engineering activities proactively.
- Execute system engineering within the defined scope, comply with working agreements with teams, making timely and effective decisions to achieve closure on work items.
- Develops and implements new product designs and design improvements ensuring alignment with customer requirements.
- Participates in the technical development of a Continuous Integration and Continuous Deployment framework for multiple initiatives, ensuring process optimization and efficiency.
- Conducts preliminary studies and modifies subsystem designs to address complex problems, deriving specifications from customer requirements and ensuring adherence to regulatory standards and company quality systems.
- Collaborates with engineers to devise integration phases, criteria, and tests, assists in the designing of features for digitally assisted medical solutions and supports installation, integration, and monitoring of external clinical sites.
- Keeps abreast of developments within the field, exchanges information effectively to promote cross-functional collaboration, interacts with stakeholders to ensure alignment on project goals and timelines.
- Conducts experimental activities related to test project outcomes, analyzes data, and evaluates results to inform decision-making and implementation of improvements.
You'll thrive in this 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 requirements management, risk management, impact assessments and traceability.
- 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
- Certified Systems Engineering Professional (CSEP).
- Hands-on experience with requirements tools like DOORS / DNG and MBSE tools.
- AI-Powered automation for system engineering.
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.
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