Validation Engineer: Medical Devices & ISO Compliance
$100k - $120kTata Consultancy Services Limited
Salary Range: $100,000-$120,000 per year Responsibilities Prepare TMV protocols and reports and perform Validation Apply Gage R&R (repeatability & reproducibility) Ability to select appropriate measurement tools (e.g., vernier/calipers, micrometers, etc.) Write clear TMV protocols and reports Create test procedures, acceptance criteria, and validation plans Interpret test methods, specifications, and engineering drawings Collaborate with Engineering, Quality, Operations, and R&D Produce clear, audit‑ready documentation to meet ISO and regulatory requirements for medical devices Train operators, engineers, and quality staff on validated inspection methods and best practice Qualifications
BACHELOR OF COMPUTER SCIENCE
Medical Device NPD experience Benefits Discretionary Annual Incentive Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans Family Support: Maternal & Parental Leaves Insurance Options: Auto & Home Insurance, Identity Theft Protection Convenience & Professional Growth: Commuter Benefits & Certification & Training Reimbursement Time Off: Vacation, Time Off, Sick Leave & Holidays Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing #J-18808-Ljbffr Tata Consultancy Services Limited- A technology company in Salem, MA, is seeking a Senior Quality Engineer to lead initiatives in quality improvement and ensure compliance with ISO 9001. The role involves reviewing deliverables, managing quality concerns, and maintaining an effective Quality Management...Suggested
$100k - $110k
...protocols and reports and perform Validation • Apply Gage R&R (... ...test methods, specifications, and engineering drawings • Apply Gage R&R (repeatability... ...ready documentation to meet ISO and regulatory requirements for medical devices. • Train operators, engineers,...Suggested- REALIGN LLC is seeking a Medical Device Validation Engineer based in Danvers, MA. The engineer will be responsible for preparing TMV protocols... ...and collaborating with various departments to ensure compliance with ISO and regulatory requirements. Candidates should have...SuggestedFull time
- REALIGN LLC is seeking a Medical Device Validation Engineer to work onsite in Danvers, Massachusetts. The ideal candidate will be responsible... ...requires collaboration with various teams to ensure compliance with ISO standards and training staff on inspection methods. This...SuggestedFull time
$165k - $200k
...seeking a Director, Quality and Compliance in Beverly, MA. This role demands... ...regulatory affairs within the medical device industry. The candidate should have a university degree in Engineering or Life Sciences, proven expertise in ISO 13485 and FDA-compliant systems,...Suggested- ...regulatory bodies. Regulatory Compliance: Ensure all products comply... ..., including FDA 21 CFR 820, ISO 13485, and CE marking... ...safety and effectiveness of medical devices after they are released to the... ...Affairs, Life Sciences, Engineering, or a related field. Experience...
- ...Job Title Required Skills: Cybersecurity experience in medical device / domain is mandatory 5+ years industry experience in Information... ...Security. Working knowledge of regulatory standards and compliance frameworks (e.g., NIST Cybersecurity Framework, ISO27001, SOC...
- ...Services, LLC is looking for a skilled Medical Device Manufacturing Engineer in Danvers, Massachusetts. The... ...involves supporting manufacturing validation, inspection methods, and quality... ...and strong skills in TMV protocols, ISO compliance, and precision measurement tools....
- ...will have at least 8-10 years of experience in quality systems, be certified as an ASQ CQA, and possess strong knowledge of FDA and ISO regulations. Responsibilities include planning and reporting on internal quality audits, gap assessments, and conducting supplier audits...Remote work
$65k - $75k
Freudenberg Group is seeking a Quality Engineer I in Beverly, MA, to ensure quality control in the manufacturing of medical devices. The role requires a Bachelor's Degree in Engineering and at least 3 years of relevant experience, particularly in a manufacturing environment...- Medtronic plc is looking for an Engineering Technician III to support extrusion operations in Danvers, Massachusetts. This full-time... ...equipment, and improving manufacturing processes for high-quality medical devices. The position requires at least a high school diploma with 4...Full time
$80k - $85k
G&F Precision Molding, Inc. is seeking a Quality Engineer to join their team in Danvers, MA. This role focuses on ensuring products meet... ...of $80K-$85K, extensive benefits including 401(k) matching, medical insurance, and a commitment to professional growth. Relocation...Relocation package- Grove Technical Resources is seeking a Sr Mechanical Design Engineer to be based in Danvers, Massachusetts. This fully onsite role involves electromechanical design of machinery, tool design, and working within a SolidWorks PDM environment. Candidates should possess a...
- Job Title: Sr Mechanical Design Engineer - Medical Device Job Location: Danvers, Massachusetts (Fully onsite) Type: W2 contract Job Start Date... ...duties may be assigned. Researches, plans, designs, verifies, validates and develops mechanical and/or electromechanical products...Contract work
$165k - $200k
...moments. Freudenberg Medical is a trusted Contract... ...production for medical device and pharmaceutical companies... ...Director, Quality and Compliance Responsibilities... ...University degree in Engineering, Life Sciences, or related... ...and maintaining ISO 13485- and FDA-compliant...Contract workVisa sponsorship- ...customer expectations. Ensure compliance with ISO 13485, 21 CFR Part 820, GMP... ...across the Freudenberg Medical business. Develop and... ...current knowledge of medical device regulations and ensure... ...Qualifications ~ University degree in engineering, life sciences, or related...
- A leading engineering firm in Beverly is seeking a Senior Mechanical Engineer with over 5 years of experience in medical devices and mechanical design. The role involves leading projects, facilitating client interactions, and mentoring team members. Candidates should have...Flexible hours
$90k - $100k
...Conduct supervised audits against ISO management system standards,... ...and management systems for compliance with applicable ISO... ...Qualifications ~ Bachelor's degree in engineering, science, environmental,... ...and safety management ~ Medical device quality systems ~...Permanent employmentFull timeContract workFreelanceLocal area- ...America (Healthcare and Medical Equipment) is Samsung’... ...software-as-a-medical-device (SaMD) portfolio... ...submissions and ensuring compliance with evolving global regulations... ...Product, Marketing, Engineering, and Clinical teams to... ...— FDA, EU MDR, ISO 13485, and relevant standards...Full timeTemporary workWorldwideFlexible hours
- Medtronic is seeking an Engineering Technician III in Danvers, MA to support extrusion operations... ...in manufacturing high-quality medical devices. You will work closely with... ...teams to enhance performance and ensure compliance with SOPs and GMPs. The role requires...
- We are seeking a skilled Medical Device Manufacturing Engineer to support manufacturing validation, inspection methods, and quality documentation activities within... ...possess strong knowledge of inspection tools, ISO compliance, and medical device regulatory documentation....
- Medtronic is seeking a Manufacturing Engineer to support daily manufacturing operations in Danvers, Massachusetts. This role... ...improvements in extrusion processes for life-saving medical devices, ensuring compliance with quality and regulatory requirements. The ideal candidate...
- A leading medical imaging firm in Danvers, MA, seeks a Senior Quality Systems Specialist to design and maintain the Quality Management... ...in a quality-related field, with expertise in regulatory compliance and strong documentation skills. Responsibilities include leading...
$96k - $192k
...Regulatory Affairs & Compliance Lead at Sensitech , you... ...(e.g., CE/MDR, FDA, ISO standards,... ...management, verification/validation, labeling, packaging,... ...consultants. Support engineering teams in testing and... ...with hardware, IoT, medical devices, or regulated electronics...Temporary workWork at officeVisa sponsorship2 days per week- ...established industry player is seeking a Project Engineer to join their dynamic team. In this role, you... ...plans, manage project documentation, and ensure compliance with quality standards. Your expertise in the medical device industry will be invaluable as you navigate...
- ...Job Description Job Description We're looking for a Senior Verification Engineer to play a key role in verifying complex SoC and subsystem designs. You'll work hands-on with design and architecture teams to ensure functionality, quality, and coverage goals are met...Full timeRemote work
$90k
...motivated and forward‑thinking Manufacturing Engineer to develop and evaluate new processes and... ...establishing procedures that confirm and validate manufacturing process requirements, and... ...and AutoCAD. Experience working in an ISO 9001 facility. Strong mechanical aptitude...Local area- ...innovators and entrepreneurs bringing In Vitro Diagnostics (IVD) and Medical Devices to market that impact the lives of millions of patients around... ...basis. The ideal candidate brings deep expertise in FDA and ISO quality systems, has hands-on lead auditor experience, and is...Hourly payContract workFor subcontractor
- ...with adherence to strict timelines. Support compliance certification activities, such as SOC2, FedRAMP, ISO 27001, etc. Identify, research, evaluate,... ...decisions that balance business needs with medical device security objectives. Work across organizational...
$94k - $151.8k
...decks, and data storytelling that drives decisions • Ensure compliance with data privacy and security policies when handling... ...., Definitive Healthcare, IQVIA, DocNexus) • Experience in medical devices, healthcare services, or life sciences • Hands-on experience...Temporary workLocal areaRemote work
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