Job Listing
|
|
| Job ID: 14533730 |
|
| |
| Job Location: |
|
| |
|
Public Transportation is Available.
|
| |
| How to Apply: | To see employer contact information, log in or register. |
| |
| Job Title: | Design Quality Software Engineer |
| Work Type: | Work Days: Weekdays, Work Vary: No , Shift: First (Day), Hours Per Week: 40, Work Type: Regular |
| |
| Salary Offered: | Unspecified |
| Benefits: | Unspecified. |
| |
| Physical Required: | Unspecified |
| Drug Testing Required: | Unspecified |
| Education Required: | Bachelor's Degree |
| |
| Experience Required: | 12 Months |
| |
| Required Skills: | other |
| Preferred Skills: |
|
| |
| |
| |
|
| Job Description: |
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:
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 [email protected] or 844-463-6178.
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. https://www.eeoc.gov/eeo-policy-statement
Refer to ID 2066655 when applying |
|