Senior Software Quality Engineer - Digital Products

Manchester, NH
Full Time
Quality
Manager/Supervisor

About Sequel
Sequel Med Tech is an early-stage company developing the next generation of precision drug delivery devices.

Job Overview

We are seeking a highly skilled Senior Software Quality Engineer - Digital Products to join our Quality organization. Reporting to the Director of Quality, the Senior Software Quality Engineer will support quality efforts for the development and distribution of software product, including design and development as required and validation and verification efforts for the software components of Sequel’s medical device products. The ideal candidate will have extensive experience in software quality assurance within the medical device industry, ensuring compliance with applicable standards and regulations throughout the software development lifecycle.

Job Responsibilities and Essential Duties

  • Provide quality engineering support for software project teams throughout the software lifecycle, from design through launch, ensuring integration of quality into software development, scientific computation, and data acquisition functions.
  • Ensure compliance with FDA Quality System Regulation (QSR), ISO 13485, ISO 14971, and IEC 62304 standards.
  • Develop and maintain software quality assurance plans, including risk management and validation strategies, to ensure compliance with regulatory requirements.
  • Collaborate with cross-functional teams, including software development, regulatory affairs, and clinical teams, to ensure alignment on quality objectives and regulatory expectations.
  • Participate in design reviews, code reviews, and other technical assessments to identify potential quality and compliance issues early in the development process.
  • Conduct audits and assessments of software development processes and deliverables to ensure adherence to internal procedures and regulatory standards.
  • Provide guidance and training to software development teams on best practices for software quality assurance and regulatory compliance.
  • Lead the investigation and resolution of software-related quality issues, including root cause analysis and implementation of corrective and preventive actions.
  • Stay current with evolving regulatory requirements and industry best practices related to software quality assurance and medical device software development.
  • Partner with QA team on software quality documentation.
  • Work closely with the software engineering team to implement and maintain a robust software quality management system.
  • Follow agile practices in the development of medical software products, including TIR45, PCCP, or other models for agile software compliance.
  • Communicate project and compliance issues to Quality Systems Management and provide solutions to mitigate potential risks

Minimum Requirements

  • 5+ years' experience in software quality engineering within the medical device industry.

Required Knowledge, Skills and Abilities

  • Strong understanding of FDA regulations, ISO 13485, IEC 62304, and 21 CFR Part 11.
  • Experience with risk management processes and tools, including FMEA and fault tree analysis.
  • Proven ability to work effectively in cross-functional teams and communicate complex quality and regulatory concepts to diverse stakeholders.
  • Excellent problem-solving skills and attention to detail, with a proactive approach to identifying and addressing potential quality issues.
  • Certification in quality engineering (e.g., ASQ CQE) is a plus.
  • Experience in a startup or fast-paced environment is a plus

Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

At Sequel, we believe that when you thrive, we thrive. That’s why we’ve designed a benefits package that’s as thoughtful as it is generous. From day one, you’re automatically enrolled in our 401k plan—no waiting, no worries—with a 6% company match and 100% immediate vesting. We prioritize your well-being, especially for our employees and their families living with diabetes, with capped out-of-pocket insulin costs and GLP-1 coverage across all plans. With multiple medical plans through Aetna, including a 100% company-paid high deductible plan paired with employer HSA contributions, you can select what suits your needs. Additional benefits include vision and dental plans, employer-paid short-term disability, and voluntary options like accident and pet insurance.

Need time to relax and recharge? You’ll enjoy flexible PTO and generous paid holidays, all while being part of a culture that values hard work, fun, and support. We don’t just offer jobs—we offer careers that build futures. Join us, and let’s grow together!

Environmental/Safety/Physical Work Conditions

  • Ensures environmental consciousness and safe practices are exhibited in decisions
  • Use of computer and telephone equipment and other related office accessories/devices to complete assignments May work extended hours during peak business cycles
  • Physical requirements such as lifting specific weights
  • Some travelling is expected
Share

Apply for this position

Required*
We've received your resume. Click here to update it.
Attach resume or Paste resume
Attach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) or Paste resume

Paste your resume here or Attach resume file

To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more.
Invitation for Job Applicants to Self-Identify as a U.S. Veteran
  • A “disabled veteran” is one of the following:
    • a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or
    • a person who was discharged or released from active duty because of a service-connected disability.
  • A “recently separated veteran” means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
  • An “active duty wartime or campaign badge veteran” means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
  • An “Armed forces service medal veteran” means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
Veteran status


Voluntary Self-Identification of Disability
Voluntary Self-Identification of Disability Form CC-305
OMB Control Number 1250-0005
Expires 04/30/2026
Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Please check one of the boxes below:

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

You must enter your name and date
Human Check*