Iso 13485 jobs in massachusetts

Bellingham, Massachusetts

•

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

R&D Engineer

Mansfield, Massachusetts

•

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

Easy Apply

Full-time

$30 - $34 per hour

Associate Failure Analysis Engineer

Acton, Massachusetts

•

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

Easy Apply

Full-time

$51 - $52 per hour

Mechanical Engineer

Foxborough, Massachusetts

•

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

Easy Apply

Full-time

Injection Molding Maintenance Technician

Fitchburg, Massachusetts

•

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

Director, Manufacturing Operations Injection Molding

Fitchburg, Massachusetts

•

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

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

Bedford, Massachusetts

•

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/

Easy Apply

Contract

50 - 55

Technical Project/Program Management - Technical Program Manager V

Remote

•

Today

Job#: 3053591 Job Description: Technical Project/Program Management - Technical Program Manager V Compensation: $12- - $130 hourly Location: Remote, California (Remote) Role Overview We are seeking a senior Technical Program Manager with relevant Software as a Medical Device (SaMD) experience. This role focuses on managing the software release process for a key medical device feature. The position requires leading cross-functional teams to ensure deliverables are completed in accordance wit

Easy Apply

Full-time

$120 - $130 per hour

Tooling Design Engineer

Wilmington, Massachusetts

•

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

Senior Chemical Engineer

Woburn, Massachusetts

•

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

GRC Analyst

Remote

•

3d ago

This is a 3 Month Contract to Hire Opportunity. This position is 100% Remote. This is an outstanding opportunity for a Sr. GRC Analyst to participate in large global GRC initiatives that literally save lives. We are a leading global biotech company committed to improving human health through scientific innovation. With a 50+ year legacy of excellence, our publicly traded organization employs over 7,000 global team members, holds 750+ product patents, and generates $6.6 billion in revenue with $1

Easy Apply

Contract

$60 - $70

Senior Manager IT Manufacturing Applications

Remote or San Diego, California

•

Today

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insig

Full-time

USD 141,800.00 - 236,400.00 per year

Principal National Support Engineer II

Remote

•

Today

Position Overview The Principal National Support Engineer II provides the highest level of technical expertise and experience to the Fujifilm Healthcare Medical Informatics business covering all currently offered products including, but not limited to: storage systems, PACS (Radiology/Cardiology), VNA, Mobility, 3D Systems, Syncomm and Clinical Information Systems. While this position primarily supports the Technical Assistance Center (TAC), technical leadership and direction is provided to all

Full-time

USD 110,366.00 - 130,909.00 per year

Automation Engineer II

Bedford, Massachusetts

•

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

•

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

•

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

Engineer I, Operations Support Engineer

Bedford, Massachusetts

•

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

Product Quality Engineer 2

Marlborough, Massachusetts

•

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

Sr. Mechanical Engineer

Billerica, Massachusetts

•

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

Engineering Manager

Danvers, Massachusetts

•

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

Iso 13485 jobs in Massachusetts, USA