ISO 13485 jobs in Needham, 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

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

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

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

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

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

Imaging Service Engineer I (Boston, MA)

Boston, Massachusetts

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Today

Position Overview An Imaging Service Engineer I is responsible for performing scheduled service work on systems within a service area, and some unscheduled work in the service area with the assistance of technical support, as directed by the Area Service Manager. Company Overview At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a healthier world, and we need passionate, driven people like you to help us get there. Our cutting-edge healthcare solutions span diagno

Full-time

USD 32.69 - 38.46 per hour

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

Senior Chemical Engineer

Woburn, Massachusetts

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Today

Position Summary This position will play a key leadership role in the design, development, and optimization of industrial processes to turn raw materials into valuable products. You will combine your expertise in photolithography, acid chemistry, and metallurgy to deliver burr-free, stress-free micro-features that meet the stringent dimensional and biological requirements of life-critical medical devices. This role will include working with the operations, scheduling, customer service, and qual

Full-time

Engineering Manager

Danvers, Massachusetts

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Today

We anticipate the application window for this opening will close on - 19 Nov 2026 Position Description: Engineering Manager for Medtronic, Inc. in Danvers, MA. Plan, direct and implement various aspects of the design and development of new medical device products. Develop, evaluate, implement and maintain technical quality assurance and control systems standards in extrusion and assembly manufacturing pertaining to materials, techniques, and products. Select, develop and evaluate personnel to e

Full-time

USD 178,000.00 - 213,000.00 per year

Sr. Product Development Engineer - Boston, MA

Boston, Massachusetts

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Today

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we're making bette

Full-time

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

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

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

Sr. Mechanical Engineer

Billerica, Massachusetts

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Today

Azenta Inc. At Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships. All we accomplish is grounded in our core values of Customer Focus, Achievement, Accountability, Teamwork, Employee Value and Integrity Job Title Sr. Mechanical Engineer Job Description The Mechanical Engineer is responsible for the des

Full-time

USD 99,000.00 - 124,000.00 per year

ISO 13485 jobs in Needham, MA, USA