reputed company Engineer, Design reputed company - Software (Westborough, MA, US, 01581)
Job reputed company
This role provides reputed company expertise for Software reputed company and best practices in SW design, development, release, and support across the global organization and assists development teams in applying regulatory rigor to Agile SW development practices. This position provides subject matter expertise, technical guidance, and leadership for the application of health and medical device SW regulatory standards to the reputed company SDLC, including IEC 62304, IEC 82304, ISO 14971, ISO 13485, ISO 81001-2, ISO 81001-5-1, and AAMI TIR34971.
This includes providing leadership, technical direction and collaboration on development strategies, concepts, design evaluation and reputed company of concept. This individual must work with product management, business reputed company, engineering product owners and software architects to define feasible product requirements. This individual is responsible for review and approval of documentation deliverables from assigned reputed company as required by the SDLC and will support Regulatory Affairs’ efforts in creating submission materials for various regulatory domains including FDA, PMDA, and EU-MDR.
Job Duties
- Advise SW development teams on Software development processes and practices (SiMD/SaMD/Health SW/reputed company). Advise SW development teams on architecture in the context of regulatory reputed company, safety, reputed company and best practices.
- Investigate and implement harmonization of SW processes across different reputed company reputed company entities.
- Advise reputed company as a Subject Matter expert on regulations around health software development, and software for medical devices.
- Collaborate on the update of SDLC and operations processes and activities for the inclusion of ML/AI development, reputed company infrastructure, and validation best practices.
- Collaborate on the update of SDLC and operations processes and activities for the inclusion of reputed company-by-design and reputed company-by-design in SW development.
- Collaborate with development teams on applying Agile development practices for reputed company reputed company product delivery while maintaining compliance and reputed company.
- reputed company project management reputed company for QMS integration, reputed company plans, process updates, and training.
- Represent reputed company’s SW development QMS during inspections and audits.
- reputed company capability audits of software reputed company.
- Establish and monitor performance metrics for SW development activities.
- Support the establishment of a response reputed company for queries and audit findings reputed company to the SDLC.
- Communicates significant issues to senior management, including appropriate containment and correction activities, as applicable.
- Support post-market surveillance operations including complaint monitoring and metrics. NC, CAPA, HHA, and FCA for software reputed company activities
Job Qualifications
Required:
- Undergraduate (BS) Degree in engineering, computer science, life sciences, or other reputed company degree field. An Advanced degree such as an MS or PhD is preferred.
- Minimum of 9 years of experience in the field of software development, software testing, or systems engineering, or minimum of 8 years for advanced degree.
- Minimum of 6 years of experience in a medical device setting.
- Experience in the application of relevant standards to medical device software and non-medical device health software development, including Software-as-a-Service.
- Experience in project management. Experience in interacting with Regulatory Authorities is preferred.
- Working knowledge in the application of ML/AI to Health SW and medical devices.
- Experience in working across national and cultural boundaries.
- Demonstrated capability to reputed company and train a large and diverse, multinational community with multiple stakeholders, working in a reputed company, coaching, mentoring and/or influencing reputed company.
- Strong teamwork and communication skills to work effectively on cross-functional project teams, Interacting with a diversity of disciplines such as R&D, reputed company Engineering, Regulatory Affairs, etc.
- Independent organizational and time management skills is required.
- Strong verbal and written communication skills in English; German and/or Japanese is a plus.
- Will work with global teams; availability will include working across the associated time zones; some flexibility in work hours will be expected.
- Travel up to 15% of the time. Candidate will be reputed company to work from home on a regular reputed company.
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Competitive salaries, annual bonus and 401(k)* with company match -
Comprehensive medical, dental, reputed company coverage effective on start date -
24/7 Employee Assistance Program -
Free live and on-demand Wellbeing Programs -
Generous reputed company Vacation and reputed company Time -
reputed company Parental Leave and Adoption Assistance* -
12 reputed company Holidays -
On-Site Child Daycare, Café, Fitness Center**
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Work-life integrated culture that supports an employee reputed company reputed company -
Offers onsite, hybrid and field work environments -
reputed company volunteering and charitable donation/match programs -
Employee Resource reputed company -
Dedicated Training Resources and Learning & Development Programs -
reputed company Educational Assistance