Senior System Engineer
3 weeks ago
Company Overview
Digital Health Solutions is a premier
consulting company dedicated to providing comprehensive solutions to medical device companies. We specialize in helping our clients navigate the complexities of IEC 62304, ISO 13485, ISO 14971 and FDA Cybersecurity Guidance compliance. Our team of skilled professionals is committed to delivering the highest level of service, ensuring that our clients' products are both safe and effective for their end users.
We are currently seeking a talented Senior Systems Engineer to join our dynamic team. The ideal candidate will have extensive experience in system engineering, requirement management and risk management, navigating the cybersecurity guidance, as well as a deep understanding of the medical device industry.
Responsibilities
-
Develops system and subsystem requirements.
-
Participates in hardware and software design and development activities, working with engineers to ensure the design will meet requirements.
-
Participates in safety and cybersecurity risk analysis activities.
-
Leads security threat modeling and security risk mitigations.
-
Develops requirements verification protocols, ensuring the requirements may be verified in compliance with design controls and other QMS SOPs.
-
Leads requirements verification and validation activities by actively engaging in the technical work, supervising V&V engineers as needed.
-
Collaborate with cross-functional teams, including software development, quality assurance, and regulatory affairs, to ensure secure and compliant system development processes.
-
Reviews and develops technical documentation to ensure the planned activities match the system and subsystem verification and validation approach.
-
Leads and reviews reports from external testing including cybersecurity penetration testing, 60601, biocompatibility, FCC, usability
-
Participates in and leads Design Reviews and technical reviews.
-
Coordinates and presents technical data, analyses, and status at reviews (internal and external).
-
Manages technical and schedule balance while coordinating with the project manager and functional leads to ensure the planned approach meets schedule constraints.
-
Helps grow the organization by participating in interview process for engineers of various disciplines, working closely with DHS senior leadership
-
Stay current with industry trends, emerging threats, and best practices in medical devices to continuously improve our services and maintain our competitive edge.
-
Performs other tasks as required.
Qualifications
-
Bachelor's degree in engineering discipline; advanced degree preferred.
-
2 to 5 years of experience in systems engineering, with a focus on medical devices.
-
Strong knowledge of IEC 62304, ISO 13485, ISO 14971, ANSI/AAMI SW96, FDA Guidance for Cybersecurity in Medical Devices and other relevant medical device regulations and standards.
-
Demonstrated experience in conducting risk assessments and developing risk mitigation strategies for complex systems.
-
Strong knowledge of security risk management and threat modeling techniques preferred.
-
Excellent problem-solving skills and the ability to work independently or as part of a team.
-
Strong communication skills, both written and verbal, with the ability to effectively convey complex technical concepts to non-technical stakeholders.
What We Offer:
-
Competitive salary and benefits package, including health insurance, 401(k) plan with employer match, vision, dental and paid time off.
-
Opportunity to work with cutting-edge technology in the medical device industry.
-
A supportive, collaborative work environment that fosters professional growth and development.
-
The chance to make a meaningful impact on the safety and effectiveness of medical devices, ultimately improving patients' lives.
by Jobble
-
Senior Manager System Engineering
2 weeks ago
Andover, United States JCW Group Full timeJCW is working on an exciting search for a Senior Manager System Engineer for a global medical device company out of Andover, MA. This role would be 3 days onsite. The ideal candidate will be coming from a medical device regulated background with strong hardware and firmware systems knowledge. This role will be leading a team and requires prior managerial...
-
Senior Manager System Engineering
2 weeks ago
Andover, United States JCW Group Full timeJCW is working on an exciting search for a Senior Manager System Engineer for a global medical device company out of Andover, MA. This role would be 3 days onsite. The ideal candidate will be coming from a medical device regulated background with strong hardware and firmware systems knowledge. This role will be leading a team and requires prior managerial...
-
Senior Manager System Engineering
2 weeks ago
Andover, United States JCW Group Full timeJCW is working on an exciting search for a Senior Manager System Engineer for a global medical device company out of Andover, MA. This role would be 3 days onsite. The ideal candidate will be coming from a medical device regulated background with strong hardware and firmware systems knowledge. This role will be leading a team and requires prior managerial...
-
Senior Electrical Engineer
5 days ago
Andover, United States Net2source Full timePosition: Senior Electrical Engineer Location: Andover, MA (100% Onsite) Duration: Full Time Direct Hire Base Salary: $125K annually 4% annual bonus Description: ***is searching for a Senior Electrical Engineer who will support the team in design, development and commercialization of new wearable diabetes care products. We are recruiting for a highly driven...
-
Senior Electrical Engineer
1 week ago
Andover, United States Info Way Solutions Full timeSenior Electrical Engineer This role will reside in Andover, MA 5 Days in office - ONSITE ONLY Purpose: Senior Electrical Engineer who will support the team in design, development and commercialization of new wearable diabetes care products. We are recruiting for a highly driven Senior Electrical Engineer with a passion for problem solving and a proven...
-
Senior Electrical Engineer
1 week ago
Andover, United States US Tech Solutions Full timeJob Description: Searching for a Senior Electrical Engineer who will support the team in design, development and commercialization of new wearable diabetes care products. We are recruiting for a highly driven Senior Electrical Engineer with a passion for problem solving and a proven track record of successfully developing products. The Senior Electrical...
-
Senior Electrical Engineer
2 weeks ago
Andover, United States Net2source Full timePosition: Senior Electrical Engineer Location: Andover, MA (100% Onsite) Duration: Full Time Direct Hire Base Salary: $125K annually 4% annual bonus Description: ***is searching for a Senior Electrical Engineer who will support the team in design, development and commercialization of new wearable diabetes care products. We are recruiting for a highly driven...
-
Senior Electrical Engineer
3 weeks ago
Andover, United States TechDigital Corporation Full timeMed device, FDA, generating IQ/OQ Company similar to ours that realizes Main designer for the next set of circuit board, cross functionally with software and design Bright, good decision making capabilities Heaving on comm. Skills Small team only 2pp on the team Experience with: Schematic layout Circuit Design Prototype Altium 60601 PCB embecta is searching...
-
Senior Design Quality Engineer
2 weeks ago
Andover, United States TransMedics Full timeIf you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Senior Design Quality Engineer Andover, MA, US 30+ days ago Requisition ID: 1192 JOB DESCRIPTION Position: Sr. Design Quality Engineer Reports to: Senior Director, Quality Assurance ESSENTIAL JOB...
-
Senior Electrical Engineer
2 weeks ago
Andover, United States Info Way Solutions Full timeSenior Electrical EngineerThis role will reside in Andover, MA 5 Days in office - ONSITE ONLY Purpose: Senior Electrical Engineer who will support the team in design, development and commercialization of new wearable diabetes care products. We are recruiting for a highly driven Senior Electrical Engineer with a passion for problem solving and a proven track...
-
Senior Electrical Engineer
4 weeks ago
Andover, United States Net2Source Inc. Full timePosition: Senior Electrical EngineerLocation: Andover, MA (100% Onsite)Duration: Full Time Direct HireBase Salary: $125K annually4% annual bonusDescription:***is searching for a Senior Electrical Engineer who will support the team in design, development and commercialization of new wearable diabetes care products. We are recruiting for a highly driven Senior...
-
Senior Electrical Engineer
1 week ago
Andover, United States Info Way Solutions Full timeSenior Electrical EngineerThis role will reside in Andover, MA 5 Days in office - ONSITE ONLY Purpose: Senior Electrical Engineer who will support the team in design, development and commercialization of new wearable diabetes care products. We are recruiting for a highly driven Senior Electrical Engineer with a passion for problem solving and a proven track...
-
Senior Electrical Engineer
4 weeks ago
Andover, United States Net2Source Inc. Full timePosition: Senior Electrical EngineerLocation: Andover, MA (100% Onsite)Duration: Full Time Direct HireBase Salary: $125K annually4% annual bonusDescription:***is searching for a Senior Electrical Engineer who will support the team in design, development and commercialization of new wearable diabetes care products. We are recruiting for a highly driven Senior...
-
Senior Electrical Engineer
2 weeks ago
Andover, United States Info Way Solutions Full timeSenior Electrical EngineerThis role will reside in Andover, MA 5 Days in office - ONSITE ONLY Purpose: Senior Electrical Engineer who will support the team in design, development and commercialization of new wearable diabetes care products. We are recruiting for a highly driven Senior Electrical Engineer with a passion for problem solving and a proven track...
-
Andover, United States Raytheon Technologies Corporation Full timeIn Systems Integration and Test (SI&T) we integrate, verify, and validate our products. We put our systems together, exercise them in the lab or in the field, measure and analyze performance, and make sure our products work the first time and every t Systems Engineer, Communications, Integration, Systems, Engineer, Communication, Manufacturing, Technology
-
Senior Quality Engineer
5 days ago
Andover, United States Triad Engineering Full timeOur successful and well-established client is seeking a Senior Quality Engineer to join their growing team. In this role you will report directly to the Director of Process Engineering and will be a critical piece of the Operations Group. You will lead QA activities and technicians in providing verification of products compliance, ensuring operating...
-
Senior Quality Engineer
1 week ago
Andover, United States Triad Engineering Full timeOur successful and well-established client is seeking a Senior Quality Engineer to join their growing team. In this role you will report directly to the Director of Process Engineering and will be a critical piece of the Operations Group. You will lead QA activities and technicians in providing verification of products compliance, ensuring operating...
-
Senior Electrical Components Engineer
7 days ago
Andover, United States Raytheon Technologies Corporation Full timeThe Electrical Product Design and Packaging Department is looking for a qualified candidate to fill the Systems Obsolescence Manager role. This is a Program direct-support position and requires a technical understanding of piece part electronic compo Manager, Systems, Electrical, Electrical Engineer, Engineer, Applications Engineer, Manufacturing, Technology
-
Silicon Systems Engineer
3 weeks ago
Andover, United States Vicor Corporation Full timeJob Summary Vicor Product Development Engineering is hiring a motivated individual to define, develop, validate and bring to production the latest in silicon power controllers and other ICs for cutting edge power conversion products. We are seeking an individual with creativity, talent, experience and a drive for success in a collaborative work...
-
Senior Mechanical Engineer
4 days ago
Andover, United States TransMedics Full timeJob Title: Senior Mechanical Engineer Sustaining Engineering Reports to: Manager Sustaining Engineering ESSENTIAL TASKS AND DUTIES INCLUDE: Serve as hands-on, technical contributor in developing new products to support existing product lines with minimal oversight Document designs by constructing solid models, assemblies, and drawings with SolidWorks...