ISO 13485 jobs in Marlborough, MA

Foxborough, Massachusetts

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Today

Dear Candidate, My name is Manisha Singh and I am a recruiter at Stellent IT LLC. I am reaching out to you on an exciting job opportunity with one of our clients. Should you be interested, please send me a copy of your resume in word format along with your LinkedIn URL. We have a Mechanical Engineer role that is full time if you are interested. Need American born s no job shoppers. Candidates need to have a LinkedIn Profile as well. Vertical is Medical Device Mechanical Engineer - Medical Dev

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Full-time

Sr. Supplier Quality Engineer (ONLY W-2 role)

Bedford, Massachusetts

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Today

Position Title: Sr. Supplier Quality Engineer (PHIAJP00004186) Location: Bedford MA Duration: 12 months Positions Requested: 2 Hours per Week: 40 (8 hrs/day) Notes from the manager: Major focus in experienced Process Validation, Verification across plastic, metal and electronics along with problem solving for candidates to support +700 parts for part qualification for Spectrawave products. The product contains Catheter and Console (System) products. Manufacture engineering, Product Quality, and/

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Contract

50 - 55

Automation Engineer II

Bedford, Massachusetts

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description How will you make an impact? The job of the Automation Engineer II is to maintain and troubleshoot all process controls. This role primary function is to address all issues that occur on the plant floor and to escalate any c

Full-time

USD 72,600.00 - 108,900.00 per year

Staff Engineer, Quality

Waltham, Massachusetts

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Today

Work Flexibility: Onsite Join Stryker's Amplitude Vascular Systems (AVS) team in Waltham, Massachusetts as a Staff Quality Engineer. In this role, you will support manufacturing operations, supplier quality, and process performance across both existing and new products. Working closely with operations, engineering, suppliers, and cross-functional partners, you will help ensure products and manufacturing processes meet quality standards, regulatory requirements, and customer expectations. This

Full-time

USD 107,200.00 - 178,600.00 per year

Sr CAPA Engineer

Remote or Waltham, Massachusetts

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Today

PURPOSE AND SCOPE: Lead the harmonization and standardization of the product transfer process including execution and oversight of the product transfer process for assigned regional/global area. PRINCIPAL DUTIES AND RESPONSIBILITIES: Develop, implement, and maintain Global Product Transfer processes for design and manufacturing product transfer.Ensure product quality is achieved at the receiving manufacturing site level during product transfer projectsPartner with CE vertical quality, R&D team

Full-time

Validation Engineer

Boston, Massachusetts

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14d ago

Job Summary: We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products. The role involves planning and executing V&V activities, developing and executing validation protocols, supporting design verification, and ensuring compliance with FDA, ISO 13485, and internal quality system requirements. Experience with infusion pump systems or similar electromechanical medical devices is preferred. Roles & Responsibilit

Full-time

CNC Machinist II, 1st shift

Bellingham, Massachusetts

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Today

About KARL STORZ From the operating room to surgery centers and everywhere in between, KARL STORZ North America is a global leader in medical technology and advanced visualization solutions. We design specialty innovations, smart instruments and devices, integrated ecosystems, and intelligent imaging to build a more connected, software-enabled operating room. As an independent, family-owned MedTech company, we ambitiously think in generations instead of quarters to improve patients\' lives aroun

Full-time

Senior Product Quality Engineer - Aerospace & Defense

Massachusetts

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Today

About Us Founded in 2015 to develop the world's first industrially scalable laser metal additive manufacturing solution, VulcanForms is reshaping how the world manufactures critical products. We build and operate advanced digital infrastructure that enables innovation, accelerates growth, and supports sustainability across aerospace, defense, medical, and other essential industries. Through our vertically integrated capabilities, including scalable additive manufacturing and precision machining

Full-time

USD 96,000.00 - 132,000.00 per year

Product Quality Engineer 2

Marlborough, Massachusetts

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Today

Job Description Are you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a Product Quality Engineer 2 to provide engineering support for on-market medical devices. In this role, you'll lead complaint investigations, perform root cause analyses, and implement corrective and preventive actions to improve product quality and compliance. Collaborating with cross-functional teams, you'll drive process improvements, assess risks, and de

Full-time

USD 78,000.00 - 122,100.00 per year

Injection Molding Maintenance Technician

Fitchburg, Massachusetts

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Today

Injection Molding Maintenance Technician fitchburg, MA 01420 Injection Molding Maintenance Technician Fitchburg, MA | Full-Time Maintain the Equipment That Keeps Production Running Micron Solutions is seeking an experienced Injection Molding Maintenance Technician to support our thermoplastic injection molding operation in Fitchburg, Massachusetts. This role is focused on maintaining, repairing, and troubleshooting injection molding presses and molding support equipment within a manufacturin

Full-time

USD 25.00 - 35.00 per hour

Lead Product Quality Engineer - Aerospace & Defense

Massachusetts

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Today

Full-time

USD 117,400.00 - 161,500.00 per year

Senior Software Design Quality Engineer

Marlborough, Massachusetts

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Today

Job Description Position Summary The Senior Software Design Quality Engineer serves as a senior Design Quality authority for software-enabled in-vitro diagnostics (IVD) medical devices across the development lifecycle. This includes software-enabled diagnostic systems incorporating image analysis and AI/ML-based algorithms to support detection and classification of cellular abnormalities. Embedded on New Product Development (NPD) core teams, this role owns software design controls, drives inte

Full-time

USD 97,600.00 - 152,700.00 per year

CSV Validation Engineer

Boston, Massachusetts

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14d ago

Job Summary We are seeking a Medical Device Quality / CSV Validation Engineer to support quality system compliance, CAPA remediation, spreadsheet validation, and computer system/software validation activities within a regulated medical device environment. The ideal candidate will have strong knowledge of FDA 21 CFR Part 820, ISO 13485, risk Roles & Responsibilities Review spreadsheet inventories and assess validation requirements based on applicable procedures, risk, and quality standards. Perfo

Full-time

Director, Manufacturing Operations Injection Molding

Fitchburg, Massachusetts

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Today

Director, Manufacturing Operations Injection Molding fitchburg, MA 01420 Director, Manufacturing Operations - Injection Molding Director, Manufacturing Operations Thermoplastic Injection Molding | Fitchburg, MA Salary Range: $120,000 - $150,000 We are looking for a hands-on manufacturing leader with direct thermoplastic injection molding experience to lead our manufacturing operations in Fitchburg, MA. You do not need to be a current Director to be considered. This could be an excellent next

Full-time

USD 120,000.00 - 150,000.00 per year

Manager, Electrical Engineering

Marlborough, Massachusetts

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Today

Job Description Job Summary The Manager, Electrical Engineering leads the electrical engineering function for the division's capital equipment portfolio. This leader builds and develops a strong team of engineers who deliver electrical design, verification, and compliance work for new product development and for sustaining products already in the field. The role requires both technical depth and people leadership. The manager sets technical direction, makes sound design trade-offs, and partne

Full-time

Compensation information provided in the description

Engineer I, Operations Support Engineer

Bedford, Massachusetts

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardotoxic materials Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthi

Full-time

USD 24.32 - 36.49 per hour

Tooling Design Engineer

Wilmington, Massachusetts

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Today

Position Summary The Tooling Design Engineer is responsible for assistance in the design and development of new products, sustaining existing products, including reviewing product designs, creating solid models, and detailing prints. This person will work under minimal supervision and interface with internal departments both local and corporate, customers, vendors, and 3rd party partners, all of which are essential to achieving the organization?s goal of on-time in-full production delivery and h

Full-time

Associate Failure Analysis Engineer

Acton, Massachusetts

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Today

Job#: 3055335 Job Description: Position: Associate Failure Analysis Engineer Location: Acton, MA Project Duration: 3 months Rate: Negotiable Based on Experience Role Overview The Associate Failure Analysis Engineer plays an integral role in the Quality Department as a hands-on engineering role conducting post-market investigations of FDA-approved medical devices. The position requires organization skills, attention to detail, the ability to work in cross-functional teams, and a drive to acc

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Full-time

$51 - $52 per hour

Senior Systems Engineer - NetSuite

Marlborough, Massachusetts

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Today

About Sequel Sequel, headquartered in Manchester, New Hampshire, is a company developing the next generation of transformative drug-delivery advancements starting with diabetes. Sequel's approach is to look at diabetes management holistically to advance systems that make living with diabetes simpler and easier for all. Sequel's flagship product, the twiist Automated Insulin Delivery (AID) System, launched in July 2025 for people with type 1 diabetes providing them with personalized diabetes mana

Full-time

USD 125,000.00 - 165,000.00 per year

R&D Engineer

Mansfield, Massachusetts

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Today

Job#: 3054806 Job Description: R&D Engineer (Design Controls / DHF Remediation) Location: Mansfield, Massachusetts (Onsite) Type: Contract Compensation: $30-34/hr. Role Overview We are seeking an R&D Engineer to support Design History File (DHF) remediation activities for regulated healthcare products. This role will focus on assessing existing design documentation, identifying gaps against industry standards and internal procedures, developing technical rationales, and supporting design co

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Full-time

$30 - $34 per hour

ISO 13485 jobs in Marlborough, MA, USA