Overview
On Site
Full Time
Skills
Maple
Firmware
Integrated Circuit
IC
Internal Communications
Design Controls
Verification And Validation
Partnership
Risk Analysis
Application Development
Technical Writing
Problem Solving
Conflict Resolution
Cross-functional Team
Cyber Security
Quality Assurance
Inspection
Regulatory Compliance
Product Development
Software Development
Software Development Methodology
Software Testing
Issue Tracking
JIRA
Test Management
Software Configuration
Version Control
Microsoft Office
Adaptability
Management
Communication
Software Design
Medical Devices
Risk Management
ISO 9000
SAP BASIS
Law
IT Service Management
Innovation
Collaboration
Recruiting
Insurance
Finance
Professional Development
Training
Leadership
CompTIA
Customer Service
Career Counseling
Oracle Application Express
Apex
Job Details
Job#: 2066655
Job Description:
Apex Systems is currently seeking a Design Quality Software Engineer for one of our top Medical Device clients in Maple Grove, MN.
Please see below for details about this exciting growth opportunity and apply now!
About the role:
We have an exciting opportunity for a software focused Design Quality Engineer supporting a cross-functional team on development and maintenance of capital equipment firmware and software within the Interventional Cardiology (IC) division. This position will support a significant product development project with high visibility which will provide the right candidate with excellent growth potential and product development experience. This role will apply the directives of design controls supporting the software development lifecycle (SDLC), software verification and validation (V&V), risk management, product development, and regulatory and standards compliance. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
Your responsibilities include:
What we're looking for:
Required Qualifications
Preferred qualifications
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.
Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.
Job Description:
Apex Systems is currently seeking a Design Quality Software Engineer for one of our top Medical Device clients in Maple Grove, MN.
Please see below for details about this exciting growth opportunity and apply now!
About the role:
We have an exciting opportunity for a software focused Design Quality Engineer supporting a cross-functional team on development and maintenance of capital equipment firmware and software within the Interventional Cardiology (IC) division. This position will support a significant product development project with high visibility which will provide the right candidate with excellent growth potential and product development experience. This role will apply the directives of design controls supporting the software development lifecycle (SDLC), software verification and validation (V&V), risk management, product development, and regulatory and standards compliance. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
Your responsibilities include:
- Participates in the implementation of new product software, including risk management (per ISO 14971), hazard analysis, software FMEAs, security risk analysis, software design V&V,
- Applies software application development procedures and provides support to demonstrate compliance through technical documentation generation.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e. software bugs).
- Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
- Update and maintain software risk management tools (i.e. Hazard Analysis, FMEAs).
- Participate in Cybersecurity related discussions and assist supporting activities
- Assist in the design and development of software test methods and inspection procedures.
- Support regulatory submissions to notified bodies.
- Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
What we're looking for:
Required Qualifications
- Bachelor's degree in engineering, or related discipline related field of study
- A minimum of 5 years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience
- Understanding of Software Development Life Cycle (SDLC)
- Experience with software testing and issue investigation/resolution
- Experience with Issue Tracking Tools (JIRA) and requirements / test management tools
- Understanding of software configuration management (version control, Microsoft office tools)
- Adaptable and effective collaborator in a team environment and in self-directed work
- Strong communication skills (verbal & written)
- Ability to work in a highly matrixed and geographically diverse business environment
- Demonstrated use of Quality tools/methodologies
Preferred qualifications
- Prior Software Design Assurance experience
- Medical device or other regulated industry experience
- Strong knowledge of Quality System Regulation (QSR), Risk Management standards (ISO 14971) and software standards (IEC 62304 or IEC 82304)
- Experience in conducting and participating in code reviews
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.
Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.