Design Quality Assurance Engineer IV

2 months ago

Charlton, United States Disability Solutions Full time
Who we are:

As a globally independent, family operated MedTech company, we ambitiously think in generations instead of fiscal quarters. At KARL STORZ our 9,000+ global associates pride ourselves on harnessing leading technologies, precise workmanship, and dedicated customer support to support the future of medical technology as we pioneer the way forward. We are setting new standards in precision and safety, from improving diagnosis to enhancing outcomes. We see beyond the limits of traditional medicine. Because it's not just about the tools we create. It's about the lives we change. Together, we can do so much

If you are a detail-oriented engineer with a passion for compliance and technology, KARL STORZ wants you to consider our Compliance Engineer (IV) position.

In this role, you will oversee component planning with Electronics Engineers globally and play a crucial role in establishing global standards.

You'll have the opportunity to work on innovative projects, shaping the future of medical technology.

In this position, you will be instrumental in solving complex vendor-related component issues; selecting, qualifying, and ensuring compliance for components used in our cutting-edge technology. As a key technical interface between suppliers and development engineers, you will drive improvements in quality, reliability, and cost-effectiveness.

What you'll be doing:
  • Lead global initiatives in component selection, research, and documentation to meet quality, manufacturability, and regulatory requirements.
  • Develop and maintain global guidelines, including preferred parts, derating, and tolerance analysis.
  • Collaborate with Electronics Engineers on component analysis, cost reduction strategies, and specifications.
  • Manage component compliance in line with regulations like China RoHS and REACH, coordinating with QA and Material Compliance teams.
  • Facilitate end-of-life (EOL) projections and manage EOL replacement efforts with cross-functional teams.
  • Evaluate supplier change notifications, qualify changes, and provide expert support in design reviews.
  • Act as the Altium schematic and PWB design tool librarian, maintaining the global parts library.
  • Ensure compliance with global regulatory standards and provide training on component selection and characteristics.
  • Participate in product development teams to create, manage, and audit design history files and technical documentation through the design control process.
  • Ensure compliance with FDA/QSR and ISO design control regulations.
  • Develop standards of best practice to be applied to Flexible Endoscope Development projects and, as applicable, the global Product Development group.
  • Participate in and lead (as required) global project teams working to ensure continued compliance with national and international standards.
  • Responsible for participating in the Design Controls portion of all regulatory agency audits which involve Flexible Endoscope Development.
  • Perform internal audits of Design History Files, technical documentation, and FED procedures and documentation to ensure compliance.
  • Investigate and respond to corrective actions in a timely manner.
  • Serve as a point of contact for KARL STORZ Regulatory Departments.
  • Responsible for understanding the application of relevant standards to the activities of Flexible Endoscope Development, to stay current on new revisions, and to ensure compliance.
  • Performance of gap analysis for revised applicable standards.
  • Identify and review new standards to determine applicability to Flexible Endoscope Development instruments.


What you need to be considered for the role:
  • Bachelor's degree required - Mechanical, Electrical or Software Engineering preferred and a minimum of 10 years in component engineering.
  • 8 or more years of experience in a Medical Device design / manufacturing environment working under FDA and/or ISO regulations.
  • Experience in new product development of reusable medical devices required.
  • Familiarity with U.S. FDA Quality System Regulation (21 CFR Part 820) and international quality standards (ISO 13485, ISO 9001).
  • Ability to evaluate electronic component data sheets and their application in specific circuit designs preferred.


Come join a team where your expertise in compliance and engineering will directly contribute to the reliability and success of our products and improve the health of patients globally

#LI-BL1

Eligible Employee Benefits
  • Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too
  • 3 weeks vacation, 11 holidays plus paid sick time
  • Up to 8 weeks of 100% paid company parental leave; includes maternal/ paternal leave, adoption, and fostering of a child.
  • 401(k) retirement savings plan providing a match of 60% of the employee's first 6% contribution (up to IRS limits)
  • Section 125 Flexible Spending Accounts
  • Life, STD, LTD & LTC Insurance
  • We prepay your tuition up to $5,250 per year - Tuition pre-imbursement
  • Fitness reimbursement of up to $200 annually
  • And much more

KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship. Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor. Employees must comply will all applicable KARL STORZ policies and procedures.

Credentialing requirements at KARL STORZ

KARL STORZ is committed to maintaining a safe work environment for our employees and customers. Most field-based roles at KARL STORZ require hospital credentialing/health screens as a condition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.

Pay Transparency

The pay range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future. When determining a specific team member's base salary and/or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.

Equal Employment Opportunity & Reasonable Accommodation Statement

KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences. To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status, or any other protected characteristic. KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at taoperations@karlstorz.com.

Get in Contact

Name:

Contact Details:

  • Design Quality Assurance Engineer IV

    4 weeks ago

    Charlton, United States Disability Solutions Full time

    Job Title: Design Quality Assurance Engineer IVWe are seeking a highly skilled Design Quality Assurance Engineer IV to join our team at KARL STORZ. As a key member of our global organization, you will play a crucial role in ensuring the quality and compliance of our medical devices.Key Responsibilities:Lead global initiatives in component selection,...

  • Design Assurance Engineer IV

    5 days ago

    Charlton, United States KARL STORZ Endoscopy - America Full time

    Are you a detail-oriented engineer passionate about compliance and technology? Join KARL STORZ as a Design Quality Assurance Engineer IV and play a crucial role in shaping the future of medical technology!   What you'll be doing: You will oversee global component planning, establish standards, and solve complex vendor-related issues while ensuring...

  • Design Quality Assurance Engineer IV

    1 month ago

    Charlton, United States KARL STORZ Endoscopy - America Full time

    Are you a detail-oriented engineer passionate about compliance and technology? Join KARL STORZ as a Compliance Engineer (IV) and play a crucial role in shaping the future of medical technology!   What you'll be doing: You will oversee global component planning, establish standards, and solve complex vendor-related issues while ensuring compliance with...

  • Design Quality Assurance Specialist

    3 weeks ago

    Charlton, Massachusetts, United States KARL STORZ Endoscopy - America Full time

    Compliance Engineer IV Job DescriptionAre you a detail-oriented engineer passionate about compliance and technology? We're seeking a skilled Compliance Engineer IV to join our team at KARL STORZ Endoscopy - America.Key Responsibilities:Oversight of global component planning to ensure compliance with regulatory requirements.Establishment of standards and...

  • Development Engineer IV

    1 month ago

    Charlton, United States KARL STORZ Endoscopy - America Full time

    Shape the Future of Medical Technology with KARL STORZ!   Are you an experienced engineer passionate about designing life-changing medical devices? KARL STORZ is seeking a Development Engineer IV to lead the development of cutting-edge flexible endoscopes and associated technologies. This is your opportunity to work on impactful projects that enhance...

  • Development Engineer IV

    4 weeks ago

    Charlton, Massachusetts, United States KARL STORZ ENDOSCOPY Full time

    Shape the Future of Medical Technology with KARL STORZWe are seeking a highly experienced Development Engineer IV to lead the development of cutting-edge flexible endoscopes and associated technologies.Key Responsibilities:Lead the design, prototyping, testing, and production of new medical devices, focusing on flexible endoscopes and accessories.Drive...

  • Development Engineer IV

    4 weeks ago

    Charlton, United States KARL STORZ Endoscopy - America Full time

    Job DescriptionShape the Future of Medical Technology with KARL STORZ! Are you an experienced engineer passionate about designing life-changing medical devices? KARL STORZ is seeking a Development Engineer IV to lead the development of cutting-edge flexible endoscopes and associated technologies. This is your opportunity to work on impactful projects that...

  • Development Engineer IV

    4 weeks ago

    Charlton, United States Disability Solutions Full time

    Shape the Future of Medical Technology with KARL STORZ!Are you an experienced engineer passionate about designing life-changing medical devices? KARL STORZ is seeking a Development Engineer IV to lead the development of cutting-edge flexible endoscopes and associated technologies. This is your opportunity to work on impactful projects that enhance patient...

  • Development Engineer III

    4 weeks ago

    Charlton, United States Disability Solutions Full time

    Job Title: Development Engineer IIIThis is a challenging and rewarding role for a skilled Development Engineer III to join our team at Disability Solutions. As a key member of our product development team, you will be responsible for leading the design and development of new products, as well as improving existing ones.Key Responsibilities:Lead the design...

  • Test Engineer II

    2 months ago

    Charlton, United States Disability Solutions Full time

    I. POSITION SUMMARYUnder minimal supervision, provides design verification support for Karl Storz products to verify that they meet quality standards, including the design and execution of approved verification procedures, the execution of studies and troubleshooting in support of design engineering, and the training of other test engineers.II. MINIMUM...

  • Senior Mechanical Engineer

    20 hours ago

    Charlton, United States KARL STORZ Endoscopy - America Full time

    Shape the Future of Medical Technology with KARL STORZ!   Are you an experienced engineer passionate about designing life-changing medical devices? KARL STORZ is seeking a Development Engineer IV to lead the development of cutting-edge flexible endoscopes and associated technologies. This is your opportunity to work on impactful projects that enhance...

  • Test Engineer II

    4 weeks ago

    Charlton, Massachusetts, United States KARL STORZ Endoscopy - America Full time

    Design Verification/Test EngineerWe're seeking a skilled Design Verification/Test Engineer to join our team. As a key member of our engineering team, you will be responsible for developing and executing design verification test plans and procedures.Key Responsibilities:Develop and execute design verification test plans and procedures.Analyze and report test...

  • Test Engineer II

    3 weeks ago

    Charlton, Massachusetts, United States KARL STORZ Endoscopy - America Full time

    Design Verification/Test EngineerWe're seeking a skilled Design Verification/Test Engineer to join our team. As a key member of our engineering team, you will be responsible for developing and executing design verification test plans and procedures.Key Responsibilities:Develop and execute design verification test plans and procedures.Analyze and report test...

  • Development Engineer III

    1 day ago

    Charlton, United States KARL STORZ Endoscopy - America Full time

    KARL STORZ is seeking a passionate and innovative Mechanical Engineer – Product Enhancement & Development to join our dynamic team. In this role, you will drive the design and development of advanced medical devices, collaborating with cross-functional international teams to ensure our products meet the highest standards of quality and efficacy.   As a...

  • Development Engineer III

    1 month ago

    Charlton, United States KARL STORZ Endoscopy - America Full time

    KARL STORZ is seeking a passionate and innovative Development Engineer to join our dynamic team. In this role, you will drive the design and development of advanced medical devices, collaborating with cross-functional international teams to ensure our products meet the highest standards of quality and efficacy.   As a Development Engineer III, here's...

  • Development Engineer III

    1 month ago

    Charlton, United States KARL STORZ Endoscopy - America Full time

    KARL STORZ is seeking a passionate and innovative Development Engineer to join our dynamic team. In this role, you will drive the design and development of advanced medical devices, collaborating with cross-functional international teams to ensure our products meet the highest standards of quality and efficacy.   As a Development Engineer III, here's...

  • Development Engineer III

    4 weeks ago

    Charlton, United States Disability Solutions Full time

    POSITION DESCRIPTIONThis Development Engineer is responsible for project/design leadership of KS-PDI new product development projects. Primary responsibilities include development and upgrade of KARL STORZ products, both Medical and Industrial Flexible Endoscopes, including associated components and accessories, as well as the construction and testing of...

  • Development Engineer III

    4 weeks ago

    Charlton, Massachusetts, United States KARL STORZ Endoscopy - America Full time

    Unlock Your Potential as a Development Engineer IIIKARL STORZ Endoscopy - America is seeking a highly skilled and innovative Development Engineer III to join our dynamic team. As a key member of our engineering team, you will drive the design and development of advanced medical devices, collaborating with cross-functional international teams to ensure our...

  • Development Engineer III

    1 month ago

    Charlton, United States KARL STORZ Endoscopy - America Full time

    KARL STORZ is seeking a passionate and innovative Development Engineer to join our dynamic team. In this role, you will drive the design and development of advanced medical devices, collaborating with cross-functional international teams to ensure our products meet the highest standards of quality and efficacy.   As a Development Engineer III, here's...

  • Development Engineer III

    3 days ago

    Charlton, United States KARL STORZ Endoscopy - America Full time

    KARL STORZ is seeking a passionate and innovative Development Engineer to join our dynamic team. In this role, you will drive the design and development of advanced medical devices, collaborating with cross-functional international teams to ensure our products meet the highest standards of quality and efficacy.   As a Development Engineer III, here's...