Design Verification Lead

SeLux Diagnostics

SeLux Diagnostics

Boston Metropolitan Area, USA
Posted on Saturday, September 9, 2023

Selux is seeking an enthusiastic and experienced System Verification Lead to augment our stellar team of scientists and engineers. The ideal candidate will be well-versed in all aspects of medical device design verification including system and design level verification methods including device software verification, design change management and relationship to design verification, and configuration control of test units. This candidate must be capable of defining, performing, and documenting robust test plans across multiple concurrent programs while mentoring more junior team members. This candidate must be able to lead without direct management responsibility and have excellent follow-through to complete design verification and associated documentation in a timely manner.

Key Responsibilities:

  • Lead the continued test method development, planning, execution, and documentation of all aspects of design verification testing (DVT) from system integration testing down to detailed design and software verification.
  • Challenge product designs and requirements by developing rigorous tests to stress device capabilities.
  • Apply sound statistical methods to determining test sample size and data analyses.
  • Actively seek to understand and shape program deadlines and release cycles using DVT effort estimates to ensure project goals are met.
  • Provide strong project management across a diverse and dynamic set of DVT deliverables & deadlines
  • Strengthen and lead product configuration control processes and documentation
  • Work with upper management to recommend resourcing changes to improve quality of DVT output
  • Clearly communicate current DVT status to executives, project leads, and other relevant stakeholders
  • Mentor junior engineers in DVT best practices including test method development, test method validation, statistics, and rigorous and thorough documentation practices.
  • Other duties as assigned.

Preferred Qualifications:

  • BS in an engineering or scientific discipline such as Biomedical Engineering, Chemistry, Biology, Electrical Engineering, or Mechanical Engineering.
  • 6+ years’ experience in medical device development with some of that experience focused on device design verification. Experience in verification of diagnostic instrumentation is preferred.
  • Excellent working understanding of the medical device development process (FDA 21 CFR 820 and/or ISO 13485) and the role design verification plays within it.
  • Strong verification test design skills across a wide range of disciplines and measurement methods including software verification and standard biochemical laboratory techniques.
  • Ability to think critically about diverse aspects of a product design and develop challenging test conditions to demonstrate performance against established requirements.
  • Strong statistical analysis skills with an ability to confidently set test sample sizes, interpret tolerance specifications, and perform statistical analysis of data.
  • Strong organizational and work management skills. Demonstrated ability to successfully manage diverse work streams under tight timelines
  • Ability to work creatively and productively across engineering and science. Excellent interpersonal, communication, and documentation skills, with good attention to detail.
  • Desire and demonstrated ability to mentor junior team members in design verification best practices.
  • Ability to communicate and present effectively

About Selux:

Antibiotics are lifesaving drugs, but rapidly emerging antimicrobial resistance is threatening that reality. Selux’s mission is to preserve the lifesaving efficacy of antibiotics by providing diagnostic results in hours, rather than days, and we are building a multidisciplinary team of talented individuals to help achieve this mission.

Joining the Selux team will give you an opportunity to harness your talent and advance your career by working in diverse groups of high-performing teammates tackling the most important healthcare challenges.

The customers and patients we serve have diverse life experiences and so do we. Selux is focused on hiring talented people from a wide range of backgrounds and providing an environment where everyone feels that they belong. We offer a competitive benefits package including healthcare, 401K match, stock option grants, open paid time off and supportive family leave policies.

Vaccination is a requirement of employment.

Selux Diagnostics is proud to be an inclusive workplace and an Equal Opportunity Employer.

Our Values

We believe every member of the Selux team is an essential contributor to our vision of preserving the lifesaving power of antibiotics and that our strength lies not only in what we do, but how we do it. These values represent the way that Seluxors approach their work. If you're someone who is relentless, collaborative, and adaptable, Selux might be just the place for you!

  • Relentless in the pursuit of our mission: We know that every second counts for patients and we are dedicated to saving lives and fighting antimicrobial resistance.
  • Collaboration drives innovation: We’re people people through and through. We love to work and play together and believe we are capable of more when we join forces as a community.
  • Adapt with grace: The only way to achieve our goals is by staying flexible and positive when faced with uncertainty. We see challenges as opportunities to grow.