Hologic

Design Assurance Engineer 3

Hologic • $97K — $152K *
Marlborough, MA 01752In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Electrical or Software Engineering preferred
  • 2-5 years of experience in the medical device industry
  • Experience with capital medical devices with complex electromechanical systems and software preferred
  • Proficient in FDA Quality System Regulations and ISO 13485
  • Familiar with Risk Management (ISO 14971) and various medical device standards.

Responsibilities

  • Provide design assurance support for new and existing medical devices
  • Independently participate in new product development and sustainment projects
  • Collaborate with R&D on Risk Management files to assure compliance
  • Assess product change requests and their design impact
  • Conduct verification and validation activities to confirm requirements are met

Benefits

  • Comprehensive health benefits
  • Retirement savings plan
  • Continued education opportunities
  • Employee development programs
  • Flexible work environment
Full Job Description
Job Description

What to expect:
  • Provide design assurance support for new product development and on market medical devices. This role will be responsible to facilitate the application of design controls while supporting product development, manufacturing related design changes, maintaining regulatory compliance, implementing improvements for manufacturability and evaluating cost reduction efforts.
  • Participate independently on new product development project, assuring product inputs are clearly defined and assuring design verification and validation activities are appropriate and compliant to confirm inputs requirements are met. Test method validation would be an element of assuring verification/validation is acceptable.
  • Participate independently on sustaining product projects, assuring project is clearly defined and stays on task, confirming product inputs are continuing to be met, and necessary verification, validation, and risk management activities are completed..
  • Work collaboratively with R&D to coordinate design elements of Risk Management files for product to assure compliance with applicable standards and internal policies.
  • Assess change requests of product for impact to design, determine supporting information required for implementation of changes.

What we expect:
  • Responsible for independently assessing the health risk of various situations, including deviations, nonconformances, design verification failures, or proposed product changes. Must demonstrate efficient and effective analysis of situation, including problem definition and connection with associated post-market processes.
  • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, training and developing employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
  • Experienced with FDA Quality System Regulations, especially Design Control requirements, ISO 13485 and Medical Device Directive
  • Experienced with ISO 14971, Risk Management
  • Familiarity with Usability, Reliability, Electrical Safety, Software, Sterilization, Packaging, and Biocompatibility standards and requirements.

Education & Experience:
  • Technical Bachelor Degree, Electrical or Software Engineering preferred
  • 2-5 years' experience preferably in medical device industry
  • Experience with capital medical devices with complex electromechanical systems and software preferred

The annualized base salary range for this role is $97,000 to $152,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand..

About Hologic

Hologic, Inc. is an American medical technology company that develops and manufactures diagnostic products, medical imaging systems, and surgical products. The company's products are used in a wide range of medical applications, including breast cancer screening, cervical cancer screening, and osteoporosis diagnosis. Hologic is headquartered in Marlborough, Massachusetts, and has operations in North America, Europe, and Asia. The company was founded in 1985 and has grown to become one of the largest medical technology companies in the world.
Learn more about Hologic
Size
6,705 employees
Market Cap
$18.5 billion
Industry
Healthcare
Net Income
$1.3 billion
Founded
1985
5 Year Trend
+9.7%
Revenue
$4.5 billion
NASDAQ
HOLX
* Ladders Estimates

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