Senior Device Quality Engineering Lead

About the position

As the Senior Device Quality Engineering Lead, you will hold a pivotal role in ensuring the quality oversight of design control and risk management activities for combination products and medical devices. This senior-level position requires you to work closely with device development teams, medical device suppliers, and testing partners during the design and development phases, extending your support throughout the device lifecycle. Your expertise will drive the development, implementation, and continuous improvement of device-related quality processes and procedures, ensuring compliance with relevant standards and regulatory requirements. By providing strategic guidance and oversight, your role will be integral to the product quality and integrity across all modalities within the organization. This is a hybrid role that can be located either in Research Triangle Park, NC or Cambridge, MA.

Responsibilities

  • Lead quality engineering guidance and oversight for medical devices and combination products during feasibility, design control, risk management, and lifecycle management.
  • Define critical quality characteristics for device components and finished devices in collaboration with the device development team.
  • Support internal and external audits as a device or combination product Subject Matter Expert.
  • Oversee the quality review and approval of technical documentation, ensuring compliance with regulatory requirements.
  • Provide input to process manufacturing design and design transfer for robust product realization.
  • Support asset team strategies for regulatory filings, design control, and risk management.
  • Lead continuous improvement initiatives for the Quality Management System and lifecycle processes.
  • Function as the quality representative on cross-functional initiatives and device development programs.
  • Manage quality assurance interfaces with medical device suppliers and testing partners in collaboration with External Quality.

Requirements

  • Minimum of a BS in Biomedical/Mechanical Engineering or related technical or scientific discipline.
  • At least 7 years of experience in medical device and/or combination product industries.
  • Extensive knowledge of design control and risk management for medical devices.
  • Strong understanding of regulatory requirements and quality standards.
  • Excellent communication and collaboration skills.
  • Proven ability to lead cross-functional teams and initiatives.
  • Experience in leading continuous improvement initiatives within a Quality Management System.
  • Familiarity with medical device supplier and testing partner management.

Benefits

  • Medical, Dental, Vision, & Life insurances
  • Fitness & Wellness programs including a fitness reimbursement
  • Short- and Long-Term Disability insurance
  • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
  • Up to 12 company paid holidays + 3 paid days off for Personal Significance
  • 80 hours of sick time per calendar year
  • Paid Maternity and Parental Leave benefit
  • 401(k) program participation with company matched contributions
  • Employee stock purchase plan
  • Tuition reimbursement of up to \$10,000 per calendar year
  • Employee Resource Groups participation
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Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...

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