Full-Time

Senior Design Assurance Engineer

Confirmed live in the last 24 hours

Hologic

Hologic

5,001-10,000 employees

Develops medical devices and diagnostic products

Compensation Overview

$94.8k - $129.7k/yr

+ Bonus

Senior

Newark, DE, USA

In Person

Category
Diagnostics & Laboratory Professionals
Medical, Clinical & Veterinary
Required Skills
Risk Management
Requirements
  • Bachelor's Degree in Electrical Engineering or Electro-Mechanical Engineering
  • 3-5 years of experience
  • Experienced with FDA-Medical Devices-820 Quality System Regulation, especially Design Control requirements
  • ISO 13485 Medical Device Quality management System
  • ISO 14971:2019, Risk Management
  • Directive (ED)93/42/EEC (MDD) European Union Medical Device Directive
  • Regulation (EU) 2017/745 (MDR) European Union Medical Device Regulation
  • Prior experience in medical device or other highly regulated industry
  • Experienced with Good Laboratory Practices
  • Experienced with Usability, Reliability, Electrical Safety and Software standards and regulations
Responsibilities
  • Provide comprehensive support to ensure the quality, compliance, and safety of medical devices throughout their lifecycle
  • Attend all relevant meetings and efficiently manage email and other communication platforms
  • Facilitate design controls for manufacturing and design changes of marketed medical devices
  • Implement manufacturability improvements and lead or participate in business continuity projects
  • Continuously update learning assignments related to internal procedures
  • Support internal and external audits, manage NCEs, CAPAs, SSEs, QPLs, and other quality metrics
  • Assist in post-market surveillance complaint investigations
  • Implement and maintain risk management processes throughout the device product lifecycle
  • Ensure that product and design requirements are properly established, qualified, and met
  • Evaluate product change requests for their impact on design
  • Support all activities where Design Assurance is Responsible, Accountable, and Consulted during product development or transfers
  • Work within multifunctional teams to develop strategies that challenge medical device design and performance
  • Participate in developing and validating test methods, and maintain accurate records of testing strategies and outcomes
  • Conduct health risk assessments for on-market products
  • Execute risk assessments to support both on-market devices and new product development programs
Desired Qualifications
  • Bilingual is a plus
  • ASQ Certified Quality Engineer
  • Six Sigma Certification

Hologic focuses on improving health through early detection and treatment solutions in the medical technology field. The company develops and sells medical devices and diagnostic products, particularly in areas like breast and skeletal health, GYN surgical products, and medical aesthetics. Their products work by providing reliable diagnostic tools that help healthcare providers identify diseases early and treat them effectively. Hologic stands out from competitors by its strong commitment to quality and innovation, ensuring that their solutions meet critical health needs. The goal of Hologic is to enhance health and well-being globally by offering advanced medical technologies that support healthcare professionals and improve patient outcomes.

Company Size

5,001-10,000

Company Stage

IPO

Headquarters

Santa Clara, null

Founded

1985

Simplify Jobs

Simplify's Take

What believers are saying

  • AI-driven diagnostic tools enhance early detection and operational efficiency in healthcare.
  • The global AI medical imaging market is projected to grow significantly by 2028.
  • Increasing breast cancer prevalence boosts demand for Hologic's screening and diagnostic solutions.

What critics are saying

  • Potential private equity takeover could lead to strategic shifts misaligned with current goals.
  • Closure of Connecticut plant and layoffs may impact production capacity and morale.
  • Increased competition in AI mammography technology pressures Hologic to innovate rapidly.

What makes Hologic unique

  • Hologic specializes in breast and skeletal health, diagnostics, and GYN surgical products.
  • The company is a leader in AI-driven mammography technology for early cancer detection.
  • Hologic's global presence spans key markets like the USA, China, and Europe.

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Benefits

Health Insurance

401(k) Retirement Plan

Performance Bonus

Company News

Business Insider
May 27th, 2025
TPG, Blackstone $16B Offer for Hologic

TPG and Blackstone have proposed a deal to take Hologic private, valuing the company at $16.3-$16.7 billion, including debt, according to the Financial Times. Although Hologic recently rejected the non-binding offer, there remains a possibility for renewed discussions. The news also mentions Hologic's trading halt due to volatility, and recent price target adjustments by Stephens and Morgan Stanley.

The ICE Community
Apr 25th, 2025
New Data on Hologic's AI-Powered Mammography Technology to Be Presented at SBI

Hologic Inc. will have a strong presence at the Society of Breast Imaging (SBI) Annual Symposium in Colorado Springs, Colorado, including the presentation of pivotal new research conducted by a top-tier healthcare facility focused on the company's AI-driven mammography technology.

Business Wire
Feb 25th, 2025
Hologic to Webcast Presentation at the Raymond James 46th Annual Institutional Investors Conference

Hologic to webcast presentation at the Raymond James 46th Annual Institutional Investors Conference.

ETF Daily News
Jan 11th, 2025
Diversified Trust Co Makes New Investment in Hologic, Inc. (NASDAQ:HOLX)

Diversified Trust Co makes new investment in Hologic, Inc. (NASDAQ:HOLX).

WB Journal
Dec 23rd, 2024
Results: How did WBJ do with 2024's bold predictions?

The industry is still right-sizing itself after its rapid expansion in the wake of COVID-19, and a few companies laid off dozens of employees: Marlborough-based Sumitomo Pharma America laid off 53, and Marlborough-based Hologic is closing a plant in Connecticut, resulting in 86 layoffs.