Senior Software Design Quality Engineer

Job Title: Senior Software Design Quality Engineer
Start Date: ASAP
Salary Range: $110,000 - $160,000/year
Travel: Onsite 3 days per week in Danvers, MA
Benefits: Eligible for Health, Dental, Vision, 401K, PTO
Must be authorized to work in the U.S. This position is not eligible for sponsorship.

The Senior Software Design Quality Engineer position will support various New Product Development and sustaining activities as well as play a key role in product risk management, cybersecurity, change controls, test reviews, and design controls.

This engineer should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. Be ready to make a significant contribution to a dynamic, fun, multi-disciplinary team, where a self-motivated engineer with excellent written and verbal communication skills stands ready to succeed.

Seize the opportunity today to join this collaborative, high performing team within the fastest growing business in MedTech.  

Key Responsibilities:

• Drive quality focused design and development of software within the software development lifecycle (Agile/waterfall/SAFe/DevOps) by defining the requirements, design, verification and validation plan and strategies while maintaining traceability.

• Use Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) technical expertise, knowledge, and experience to rapidly innovate the company's medical devices for use in chronic heart failure patients.

• Lead and conduct risk management activities including development of Risk Management Plans, Hazard Analyses, Software Failure Modes and Effects Analysis (SFMEA) and Risk Management Reports.

• Drive assessments of end user needs, standards requirements, and risk evaluations to generate design requirements and engineering targets which include but are not limited to software detailed designs, software architecture and specifications.

• Ensure that Design Controls are compliant with IEC 62304.

• Ensure that FDA and other regulatory knowledge and experience is applied to risk management, software development and testing.

• Participate in software development sprint cycles by supporting the software development team through attending SCRUMs, design reviews, code reviews and providing feedback on software verification and validation deliverables.

• Develop and/or review test protocols, reports, and engineering summaries

• Participate in product cybersecurity activities including product security planning, threat analysis, cybersecurity risk assessments, periodic monitoring and reporting.

• Review and approve Change Requests as needed to release software revisions to production/field.

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities.

• Drive the success of the Quality System performance measures by completing tasks on time and with a high level of Quality

• Provide support during Corrective and Preventive Action (CAPA) activities and manage the CAPA system as necessary.

• Support 3rd party audits, including follow-up on actions.

• Drive compliance of QMS through authoring and updating Standard Operating Procedures (SOP).

Qualifications

Education:

• A minimum of a Bachelor's degree in an engineering or scientific discipline is required. An advanced degree in a related field is also an asset.

Experience and Skills

Minimum Requirements:

• A minimum of 5 years of related work experience within the medical device industry on SaMD and SiMD systems.

• Experience with quality engineering under quality system regulations, including but not limited to 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR.

• Experience with software development lifecycle processes (waterfall, agile, and DevOps) as applied within the regulated medical device industry.

• Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team and international.

Preferred Qualifications:

• Work experience with Class III medical device capital equipment development

• Experience with owning, conducting and maintaining risk management activities, including the risk management file.

• Experience with JAMA and Atlassian suite of tools (JIRA/Confluence)

• Experience with cybersecurity within a regulated industry.

Other:

• This position will require to work hybrid in Danvers, MA with a minimum of 3 days per week and will require 10% of domestic and/or international travel.