Senior Software Design Quality Engineer
Danvers, MA, 01923
Reference ID: 32793398
Date Posted: 08/27/2026
Job Title: Senior Software Design Quality Engineer
Start Date: ASAP
Salary Range: $110,000 - $160,000/year
Travel: Onsite 3 days per week in Danvers, MA
Benefits: Eligible for Health, Dental, Vision, 401K, PTO
Must be authorized to work in the U.S. This position is not eligible for sponsorship .
The Senior Software Design Quality Engineer position will support various New Product Development and sustaining activities as well as play a key role in product risk management, cybersecurity, change controls, test reviews, and design controls.
This engineer should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. Be ready to make a significant contribution to a dynamic, fun, multi-disciplinary team, where a self-motivated engineer with excellent written and verbal communication skills stands ready to succeed.
Seize the opportunity today to join this collaborative, high performing team within the fastest growing business in MedTech.
Key Responsibilities:
-
Drive quality focused design and development of software within the software development lifecycle (Agile/waterfall/SAFe/DevOps) by defining the requirements, design, verification and validation plan and strategies while maintaining traceability.
-
Use Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) technical expertise, knowledge, and experience to rapidly innovate the company's medical devices for use in chronic heart failure patients.
-
Lead and conduct risk management activities including development of Risk Management Plans, Hazard Analyses, Software Failure Modes and Effects Analysis (SFMEA) and Risk Management Reports.
-
Drive assessments of end user needs, standards requirements, and risk evaluations to generate design requirements and engineering targets which include but are not limited to software detailed designs, software architecture and specifications.
-
Ensure that Design Controls are compliant with IEC 62304.
-
Ensure that FDA and other regulatory knowledge and experience is applied to risk management, software development and testing.
-
Participate in software development sprint cycles by supporting the software development team through attending SCRUMs, design reviews, code reviews and providing feedback on software verification and validation deliverables.
-
Develop and/or review test protocols, reports, and engineering summaries
-
Participate in product cybersecurity activities including product security planning, threat analysis, cybersecurity risk assessments, periodic monitoring and reporting.
-
Review and approve Change Requests as needed to release software revisions to production/field.
-
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities.
-
Drive the success of the Quality System performance measures by completing tasks on time and with a high level of Quality
-
Provide support during Corrective and Preventive Action (CAPA) activities and manage the CAPA system as necessary.
-
Support 3rd party audits, including follow-up on actions.
-
Drive compliance of QMS through authoring and updating Standard Operating Procedures (SOP).
Qualifications
Education:
-
A minimum of a Bachelor's degree in an engineering or scientific discipline is required. An advanced degree in a related field is also an asset.
Experience and Skills
Minimum Requirements:
-
A minimum of 5 years of related work experience within the medical device industry on SaMD and SiMD systems.
-
Experience with quality engineering under quality system regulations, including but not limited to 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR.
-
Experience with software development lifecycle processes (waterfall, agile, and DevOps) as applied within the regulated medical device industry.
-
Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team and international.
Preferred Qualifications:
-
Work experience with Class III medical device capital equipment development
-
Experience with owning, conducting and maintaining risk management activities, including the risk management file.
-
Experience with JAMA and Atlassian suite of tools (JIRA/Confluence)
-
Experience with cybersecurity within a regulated industry.
Other:
-
This position will require to work hybrid in Danvers, MA with a minimum of 3 days per week and will require 10% of domestic and/or international travel.
-
Electrical Engineer
Danvers, MA, 01923
Job Title: Senior Electrical Engineer Location: Onsite (5 days/week) in Danvers, Massachusetts Start Date Is: ASAP Duration: 1 Year Contract Compensation Range: $75-$85/hour W2 Benefits: Eligible for Health, Dental, Vision, 401K Must be authorized to w...
Date Posted: 08/27/2026 Recommended
-
IAM Engineer
Salem, NH, 03079
Apply now: IAM Engineer, Remote (East Coast). Start date is ASAP for this 6-month contract position with option to extend. Job Title: IAM Engineer Location: Remote - East Coast Only! Start Date: ASAP (within 2 weeks of offer) Duration: Contract, 6 mont...
Date Posted: 08/27/2026 Recommended
-
Lead Product Engineer
Charlottesville, VA, 22911
Apply now: Lead Product Engineer, location is Remote. The start date is ASAP for this 2–3 month Contract-to-Hire position. Job Title: Lead Product Engineer Location-Type: Remote – U.S., EST hours preferred Start Date Is: ASAP Duration: 2–3 Month Contra...
Date Posted: 08/27/2026 Recommended
-
Principal Software Engineer
Windsor, CT, 06006
Job Title: Principal Software Engineer / Lead (.NET) Location-Type: Hybrid - Windsor, CT (4 days onsite per week) Start Date: To be confirmed Duration: Contract-to-Hire Compensation Range: $52/hr - $75/hr Benefits: Eligible for Health, Dental, Vision, ...
Date Posted: 08/27/2026 Recommended
-
Requirements Engineer
West McLean, VA, 22102
Apply now: Requirements Engineer, location is Hybrid. The start date is August 24 or August 31 for this contract-to-hire position. Job Title: Requirements Engineer Location-Type: Hybrid (Tysons, VA – Tuesday through Thursday Onsite) Start Date Is: Augu...
Date Posted: 08/27/2026 Recommended
-
Lead Software Engineer
Baltimore, MD, 21202
Apply now: Lead Software Engineer, location is Hybrid. The start date is June 22 or June 29 for this 6 month contract-to-hire position. Job Title: Lead Software Engineer Location-Type: Hybrid (3 Days A Week Onsite - at one of the following locations; B...
Date Posted: 08/27/2026 Recommended
-
Senior Hardware Engineer
Allentown, PA, 18109
Apply now: Senior Test Hardware Engineer, Onsite - Allentown, PA Job Title: Senior Test Hardware Engineer Location-Type: Onsite, Allentown, PA Start Date: ASAP Duration: Permanent Compensation Range: $150,000- $180,000 Bonus/RSUs Benefits: Eligible for...
Date Posted: 08/27/2026 Recommended
-
Senior Hardware Engineer
Fort Collins, CO, 80525
Apply now: Senior Hardware Engineer, Onsite - Fort Collins, CO. Job Title: Senior Hardware Engineer Location-Type: Onsite, Fort Collins, CO Start Date: ASAP Duration: Permanent Compensation Range: $150,000- $180,000 Bonus/RSUs Benefits: Eligible for He...
Date Posted: 08/27/2026 Recommended
-
Business Analyst, Data Management
Owings Mills, MD, 21117
Apply now: Business Analyst, Data Management, location is Hybrid. The start date is September 21 for this contract-to-hire position. Job Title: Business Analyst, Data Management Location-Type: Hybrid – Colorado Springs, CO or Owings Mills, MD (4 days o...
Date Posted: 08/27/2026 Recommended
-
Web Engineer/Consultant
Springfield, VA, 22150
Apply now: Web Engineer / Consultant, location is Onsite. The start date is September 28 for this permanent position. Job Title: Web Engineer / Consultant Location-Type: Onsite – Springfield, VA (5 days/week in secure client environment) Start Date Is:...
Date Posted: 08/27/2026 Recommended
-
Group Product Manager, Platforms
Centerville, VA, 20120
Job Title: Group Product Manager – Platform Location-Type: Remote (U.S. Based) Travel Start Date Is: ASAP Employment Type: Full-Time / Permanent Travel: Approximately 2–3 days per month for team meetings and occasional client visits Compensation Range:...
Date Posted: 08/27/2026 Recommended
-
Compliance Specialist
Wilmington, DE, 19805
Apply now: Compliance Specialist, Remote (Wilmington, DE area preferred). Start date is ASAP for this contract position. Job Title: Compliance Specialist Location-Type: Remote (Wilmington, DE area preferred) Start Date: ASAP Duration: 6 months- potenti...
Date Posted: 08/27/2026 Recommended
-
Digital Solutions Engineer
Boston, MA, 02115
Apply now: Digital Solutions Engineer, Hybrid (Boston, MA). Start date is ASAP for this 6-month contract position. Job Title: Digital Solutions Engineer Location-Type: Hybrid, 3 days onsite, Boston, MA Start Date: ASAP Duration: Contract, 6 months Comp...
Date Posted: 08/27/2026 Recommended
-
Sr Account Supervisor (Oncology)
New York, NY, 10011
Job Title: PR Senior Account Supervisor (Health/Oncology) Location-Type: Remote (Preferred: NYC, Chicago, or DC; 3 days/week onsite required if converted to FTE) Start Date Is: ASAP Duration: Contract through EOY (Contract-to-Hire ideal) Compensation R...
Date Posted: 08/27/2026 Recommended
-
Instructional Technologist
Baltimore, MD, 21218Apply now: Instructional Technologist, location is Remote. The start date is ASAP for this contract position. Job Title: Instructional Technologist Location-Type: Remote Start Date Is: ASAP Duration: Contract through June 2027 (20 Hours/Week) Compensat...
Date Posted: 08/27/2026 Recommended
-
Lead UX Researcher
San Francisco, CA, 94110
Apply now: Principal UX Researcher, location is Remote. The start date is ASAP for this 1-year contract position. Job Title: Principal UX Researcher Location-Type: Remote – must be able to work PST hours Start Date Is: ASAP Duration: 1 year (contract) ...
Date Posted: 08/27/2026 Recommended
-
QA Analyst
Baltimore, MD, 21201
Apply now: QA Analyst, location is Remote. The start date is ASAP for this 4-month contract position. Job Title: QA Analyst Location-Type: Remote (EST Hours) Start Date Is: ASAP Duration: 4-Month Contract (Potential Extension) Compensation Range: $55/h...
Date Posted: 08/27/2026 Recommended
-
AI Operations Lead
New York, NY, 10016
Position: AI Agent Platform Lead Location: Hybrid NY, NY; Hartford; CT; Boston, MA; Wellesley, MA; Chicago,IL Duration: 3 month contract to hire Rate: $75-80/hr W2 Role Summary Our client is seeking a hands-on AI Agent Platform Lead to build and scale ...
Date Posted: 08/27/2026 Recommended
-
Network Security Engineer
Wilmington, DE, 19805
Apply now: Network Security Engineer, Remote (EST Preferred). Start date is ASAP for this Contract-to-Hire position. Job Title: Network Security Engineer Location-Type: Remote, EST timezone preferred; occasional on-site in Delaware a plus but not requi...
Date Posted: 08/27/2026 Recommended
-
Client Implementation Project Manager
Chicago, IL, 60602
Job Title: Client Implementation Project Manager Location-Type: Remote (CST hours) Start Date Is: 2 weeks from offer Duration: 6 Months, high chance of extension or conversion to full time Compensation Range: $45-52/hr w2 Benefits: Eligible for Health,...
Date Posted: 08/27/2026 Recommended
-
Marketing & Product Data Specialist
Pennsauken, NJ, 08110
Job Title: Marketing & Product Data Specialist Location: Pennsauken, NJ – Onsite Schedule: Monday–Thursday, 7:30 AM–6:00 PM | Fridays Off Employment Type: Permanent / Full-Time Compensation: $75,000–$90,000 Bonus Start Date: ASAP Benefits: Eligible for...
Date Posted: 08/27/2026 Recommended
-
Front-End Web Developer
Weymouth, MA, 02189
Apply now: Front-end Web Developer , location is hybrid . The start date is ASAP for this 6 month contract to hire position. Job Title: Front-End Web Developer Location-Type: Hybrid Onsite - Weymouth, MA Start Date Is: ASAP Duration: Contract to Hire C...
Date Posted: 08/27/2026 Recommended
-
Project Manager III
Racine, WI, 53403
Apply now: Project Manager, Hybrid (Racine, WI). Start date is To be confirmed for this Contract position. Job Title: Project Manager Location-Type: Hybrid (Racine, WI, onsite once a month in weeklong periods; travel reimbursed) Start Date: 2 weeks fro...
Date Posted: 08/27/2026 Recommended
-
BIM Manager
New York, NY, 10001
Job Title: BIM Manager Location-Type: REMOTE Start Date Is: ASAP Duration: FTE Permanent Compensation Range: $120-150k/yr Benefits: Eligible for Health, Dental, Vision, 401K, PTO Must be authorized to work in the U.S. This position is not eligible for ...
Date Posted: 08/27/2026 Recommended
-
BIM Manager
New York, NY, 10001
Job Title: BIM Manager Location-Type: REMOTE (EST Hours) Start Date Is: ASAP Duration: FTE Permanent Compensation Range: $120-150k/yr Benefits: Eligible for Health, Dental, Vision, 401K, PTO Must be authorized to work in the U.S. This position is not e...
Date Posted: 08/27/2026 Recommended
-
Cyber Security Sr. Project Manager
Northbrook, IL, 60062
Apply now: Cyber Security Sr. PM, Location is REMOTE. Start date is ASAP for this 12-month contract position. Job Title: Cyber Security Sr. PM Location-Type: REMOTE Start Date: ASAP Duration: Contract, 12 months Compensation Range: $60-70/hr Benefits: ...
Date Posted: 08/27/2026 Recommended
-
Business Analyst, Data Products / Platforms (Joel)
Owings Mills, MD, 21117
Apply now: Business Analyst, Data Products / Platforms, location is Hybrid. The start date is September 21 for this contract-to-hire position. Job Title: Business Analyst, Data Products / Platforms Location-Type: Hybrid – Colorado Springs, CO or Owings...
Date Posted: 08/27/2026 Recommended
-
Manager
New York, NY, 10065
Job Title: Store Manager Location-Type: Onsite (Madison Ave) Start Date: ASAP Duration: Permanent Compensation Range: $80-120K commission Benefits: Eligible for Health, Dental, Vision, 401K, PTO Must be authorized to work in the U.S. This position is n...
Date Posted: 08/27/2026 Recommended
-
Infrastructure Coordinator
Boston, MA, 02115
Apply now: Infrastructure Coordinator, location is hybrid. The start date is ASAP for this 1 year Contract position. Job Title: Infrastructure Coordinator Location-Type: Hybrid - Boston, MA Start Date Is: ASAP Duration: Contract Compensation Range: 55-...
Date Posted: 08/27/2026 Recommended
-
Product Manager - Subscription/Companion Growth
Santa Monica, CA, 90404
Apply now: Product Manager – Companion Growth, location is Remote. The start date is ASAP for this 6 month contract position. Job Title: Product Manager (Subscription / Growth) Location: 100% Remote Start Date Is: ASAP Duration: 6 month contract (40 ho...
Date Posted: 08/27/2026 Recommended