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Medical Device Manufacturing Engineer Jobs

Quality Engineer (Medical Device)
By Abras Life sciences At Greenville, NC, United States
• Conduct risk assessments to identify potential hazards and to ensure that products meet safety requirements.
• Ensure compliance with regulatory requirements, including FDA regulations, ISO standards, and other applicable regulations.
• Minimum of 3 years of experience as a Quality Engineer in the medical device industry.
·Knowledge of design control and verification/validation processes.
• Develop and implement quality control plans and procedures, including documentation, training, and auditing processes.
• Conduct statistical analysis of quality data to identify trends and opportunities for improvement.
Research And Development Medical Device Engineer
By Cresilon At Brooklyn, NY, United States
Working knowledge of FDA requirements as per 21 CFR 820 and ISO 9001, ISO 13485:2003 and ISO 14971:2007 is strongly preferred.
Define new product functional requirements (design inputs/user needs) and evaluate the design's overall effectiveness, cost, reliability, and safety.
Apply strong problem-solving skills to find solutions to complex problems.
Manage part-time staff as a research leader and mentor for ongoing research projects.
Responsibilities may include other duties as assigned and as requiread
Experience gathering user needs, translating them to technical inputs, developing viable V&V (Design Verification and Validation) plans required.
Intern, Medical Device Jobs
By Curia At , Lebanon, 08833, Nj
Interpret and communicate test results to senior management
Participate in routine testing, method develop and validation as per ISO and ASTM and/or client requirements
Develop a working knowledge of the test methods being used to analyze samples
Good written, math and verbal skills, highly organized and decision-making ability focused around details
Operate test equipment for integrity and functional testing
Ability to work independently, take initiative and handle multiple tasks within defined timelines
Medical Device Electrical Engineer
By TMC At , New York, Ny
Proven experience in designing electrical systems and components for medical devices or similar regulated industries.
Knowledge of safety considerations, electromagnetic compatibility (EMC), and electrical safety standards for medical devices.
Experience with prototyping, testing, and measurement equipment for electrical systems.
Excellent problem-solving skills and ability to troubleshoot and debug complex electrical systems.
Effective communication and teamwork abilities to collaborate with cross-functional teams.
Yearly training personal budget for Coaching & Education
Ceo - Medical Device
By Leaman Life Sciences At United States
Exceptional leadership and management capabilities, with a track record of building and developing high-performing teams.
Solid financial management skills, including budgeting, forecasting, and analysis.
In-depth knowledge of regulatory requirements, quality systems, and industry standards for medical devices.
Excellent strategic thinking and problem-solving skills, with the ability to make informed decisions in a fast-paced and dynamic environment.
Strong interpersonal and communication skills, with the ability to engage and influence diverse stakeholders.
Bachelor's degree in a relevant field (e.g., engineering, life sciences, business administration). Advanced degree (e.g., MBA) preferred.
Validation Quality Engineer Ii (Medical Device)
By STAAR Surgical At Monrovia, CA, United States
• Excellent project management, organization, writing, communication and presentation skills required.
10. Compile Quality metrics, analyze trends and report to Quality Management.
13. Perform additional duties as assigned by Management.
• Bachelor’s degree, preferably in Engineering or sciences or equivalent combination of education/experience.
9. Coordinate contractor qualification activities with appropriate departments.
• Experience in vision care or intraocular lens industry preferred.
Validation Quality Engineer (Medical Device)
By STAAR Surgical At Lake Forest, CA, United States
•Excellent project management, organization, writing and presentation skills required.
.Prepare and report appropriate metrics to executive management.
•Demonstrated expert knowledge of Windows-based software, including Word, Excel, Access, Project, and Power Point.
•A Bachelor of Science (BS) in science or engineering, advanced degree preferred.
•Solid understanding of investigation techniques including design of experiments and root cause analysis.
•Demonstrated understanding and application of Quality System Auditing and Analysis
Quality Supervisor - Medical Device
By Highlander Consultants At Jacksonville, FL, United States
• Candidates must have a bachelor's degree or an equivalent combination of education and experience.
• Manage processes and employees for tasks within design quality.
• Manage daily activities of team members and leads.
• QA experience in the medical device industry would be a plus.
• Strong interpersonal skills with the ability to effectively communicate at all levels internally, as
• Must comprehend the entire portfolio of our medical device products.
Principal Mechanical Engineer, Medical Device Solutions
By Battelle At Columbus, OH, United States
Work with management and Team Leads to participate in developmental activities for junior staff
Project or technical task leadership experience in medical device design in an ISO13485 operational environment
Design for manufacturing experience e.g. in plastic injection molding, machined parts, sheet metal, packaging of electronics/cables, etc.
Consumer product design engineer experience
Hands on general lab skills e.g. building and testing prototypes
Experience using FEA analysis tools with a strong preference for ANSYS and/or Abaqus and plastic part experience
Electrical Engineer, Medical Device Solutions
By Battelle At Columbus, OH, United States
Excellent oral/written communication skills to support interaction with cross-functional team members and internal management
Verbal presentations to management, clients, and vendors
Working knowledge of the product design process, electronic manufacturing processes and design documentation requirements
Working knowledge and experience in risk analyses (i.e., ISO14971)
Support a development of the product design requirements and system architecture
Develop analog and digital circuit designs for subsystems or systems based upon requirements
Senior Engineer - R&D - Medical Device, Microfluidics
By Novo Nordisk At , Fremont, Ca $98,820 - $172,000 a year
Preparation and management of Design History Files or equivalent
Lead the definition and development of user needs, business needs, use cases and requirements.
Solid experience in product development, especially under Design Controls and for Design Verification & Validation
Experience working with Design Controls systems compliant with ISO 13485, MDR, 21 CFR 820 and other relevant regulations
Experience with combination product medical product development.
Experience managing collaborations, contracts and partnerships with external industry groups. Demonstrated success managing academic and clinical partners.
Device Engineer Ii Jobs
By Teva Pharmaceuticals At , West Chester, 19380, Pa
Present information and data to technical and management teams
Develop and execute feasibility testing in support of product development.
Ensure that every product is robust in design; perform engineering analysis and routinely provide evidence of robustness, reliability and efficacy.
Create technical drawings, reports, data and other documents.
Understanding of solid mechanics and fluid dynamics principles.
Perform risk analysis, FMEA etc.
Medical Device Planning Engineer
By Highlander Consultants At Jacksonville, FL, United States
Collaborates and coordinates between multiple departments: production, sales, marketing, and product management.
BS in engineering (Mechanical, Chemical, Bioengineering, or Biomedical) or equivalent field. MS or previous relevant engineering experience preferred.
1+ years of Medical Device Engineering experience
Experience communicating with / dealing with medical / hospital staff (doctors, surgeons, nurses).
Modeling software experience. 3D CAD experience and 3D printing experience.
Strong interpersonal skills with the ability to effectively communicate at all levels internally and externally.
Program Manager- Med Device Manufacturing
By Daley And Associates, LLC. At Clinton, PA, United States
2-5 years Past program or project management experience - Required
Ensures proactive project management and coordination of interdisciplinary technical design and integration needs.
Works with functions to define key needs and performance requirements across all disciplines. Responsible for capturing programmatic risks.
5-7 years Experience in global testing, manufacturing or development - Required
Demonstrated written and oral communication skills along with strong listening skills
Program Manager - Med Device Manufacturing
Medical Device Engineer, Test
By Stryker At , San Jose, 95138, Ca
Demonstrated electrical engineering problem-solving skills
Excellent analytical, problem-solving, and communication skills
Test engineering experience in a regulated industry, preferably medical device industry
Automation or scripting experience: preferably LabView, python, and/or Arduino
Bachelor’s degree (B.S.) in Electrical, Computer, or Biomedical Engineering, or equivalent
Familiarity with common electrical test methods and equipment
Medical Device Design Engineer
By Inspired Spine Enterprise LLC At , Burnsville, 55337, Mn
Work directly with top management, senior engineer, and surgeon customers to develop design input guidelines for new surgical implant systems.
Specific vision abilities required include close vision, distance vision, color vision, depth perception, and the ability to adjust focus
Comprehensive knowledge of Design History File, Design Transfer, and DMR maintenance
DESIGN CONTROL ACTIVITIES & RESPONSIBILITIES:
Employee must occasionally lift or move up to 50 pounds
The noise level in the work environment is usually moderate
Medical Device Engineer (Design Control)
By Azzur Group At ,
Experience with product lifecycle management software or Greenlight Guru preferred.
Effectively lead cross functional device development team through feasibility, design control phases and life cycle management.
Detailed understanding of principles and practice of Design Controls (CFR 820.30 / ISO 13485) and Risk Management (ISO 14971).
Experience with pre-filled syringes required.
Experience with secondary packaging preferred.
Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results.
Medical Device Engineer Jobs
By LINQM, Inc. At Irvine, CA, United States

LINQM is looking for a Medical Device Engineer. Write, Develop, execute experiments and tests, create, validate, and improve product designs and Ownership in the process validation in (IQ - ...

Process Engineer - Cumberland, Ri - Medical Device
By Michael Page At Cumberland County, NC, United States
Owning Process Validation: Coordinates validation activities with, and seeks team support from, Project Management, Manufacturing, Engineering, Quality, third Parties, etc.
Management Opportunity: ability to grow a team of engineers as the product develops
Product hands on experience in Medical Device (preferably Class II/III Med Devices e.g., Catheter/Balloon/etc.)
Knowledge of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and laboratory practices
Benefits package that includes: health, dental, 401k, PTO and more
HYBRID work schedule (Fridays work from home)
Director Of Operations | Medical Device Manufacturing | Leading Through Change
By One Eighty Collective At Salt Lake City Metropolitan Area, United States
Responsible for everything from order to cash
Lead and mentor a team of 5 direct reports with a total org around 300
Gathering data around what’s working and what’s not in order to continually improve, thinking through potential automations down the line
Make sure the team has clear direction, drive operational efficiency, and accountability, and engagement with their teams
Driving cultural and operational change, this includes leading and mentoring and living out the core values of the organization
Work with other leaders to communicate updates and strategize