Senior Engineer, Design Quality, Software

Olympus America, Inc.; Brooklyn Park (MN); Hybrid; USD 96.000 - 129.000; Vollzeit

Zusammenfassung

Olympus America, Inc. is seeking a Senior Engineer, Design Quality, Software to lead software quality practices across the SDLC, support regulatory submissions, and ensure compliance with ISO 13485, 21 CFR 820, and IEC 62304.

This role partners with global development teams and post-market operations. You will advise on software processes for release, manufacturing, and post-market monitoring, establish metrics, and help implement product security and SDLC updates.

Qualifikationen

• Undergraduate (BS) Degree in engineering, computer science, life sciences, or other related degree field.
• Minimum of 8 years of experience in software development, software testing, or systems engineering, or 6 years for advanced degree.
• Minimum of 5 years of experience in a medical device setting.
• Experience in applying relevant standards to medical device software manufacturing, release, and post-market operations.
• Experience working across national and cultural boundaries.
• Strong teamwork and communication skills to work effectively on cross-functional project teams.
• Will travel up to 15% of the time; some flexibility in work hours with global teams.

Aufgaben

• Advise SW development and operations teams on Software processes and practices including SW release, manufacturing, and post-market operations.
• Work with global cross functional teams to harmonize SW manufacturing and operations processes across Olympus entities.
• Advise as Subject Matter Expert on regulations around SW manufacturing, cloud operations, and post-market monitoring for Medical and Health Software products.
• Collaborate on updating SDLC and operations processes for manufacture, distribution, and monitoring of SW; include product security considerations.
• Represent Olympus’s SW manufacturing and post-market operations QMS during inspections and audits.
• Perform capability audits of software projects and establish performance metrics for SW manufacturing and post-market activities.

Kenntnisse

Software development

Software testing

Systems engineering

Teamwork

Communication

Leadership

Ausbildung

BS in engineering / related field

Jobbeschreibung

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Senior Engineer, Design Quality, Software

Workplace Flexibility:Hybrid

For more than 100 years,Olympus has focused on making people’s lives healthier, safer and more fulfilling.

Every day, we live by our philosophy,True to Life, by advancing medical technologies and elevating the standard ofpatient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

The Senior Design Quality Engineer provides professional expertise for Software quality and best practices in SW development across the global organization and assists development teams in applying regulatory rigor to Agile SW development practices, including SW release and manufacturing. This individual will lead Software Quality’s participation in specifying and monitoring SW manufacturing and post-market operations. The Senior Design Quality Engineer serves as a subject matter expert for the application of medical device SW regulatory standards to the Olympus SDLC, including ISO 13485, 21CFR820, IEC 62304, IEC 82304, ISO 14971, ISO 81001-2, and AAMI TIR34971/CR34971. This individual will be responsible for review and approval of documentation deliverables from assigned projects 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 and operations teams on Software processes and practices including SW release, manufacturing, and post-market operations.
• Working with global cross functional teams, explore and implement harmonization of SW manufacturing and operations processes across different Olympus legal entities
• Advise Olympus as a Subject Matter expert on regulations around SW manufacturing and cloud operations.
• Advise Olympus as a Subject Matter expert on regulations around SW post market monitoring for Medical and Health Software products.
• Collaborate on the update of SDLC and operations processes and activities for the manufacture, distribution, and operations monitoring of SW.
• Collaborate on the update of SDLC and operations processes and activities for the inclusion of product security in SW operations environments.
• Represent Olympus’s SW manufacturing and post-market operations QMS during inspections and audits.
• Perform capability audits of software projects.
• Establish and monitor performance metrics for SW manufacturing and post-market activities.
• Support the establishment of a dashboard for post market operations for SW products.
• Communicates significant issues to senior management, including appropriate containment and correction activities, as applicable.

Job Qualifications

Required:

• Undergraduate (BS) Degree in engineering, computer science, life sciences, or other related degree field.
• Minimum of 8 years of experience in the field of software development, software testing, or systems engineering, or 6 years for advanced degree.
• Minimum of 5 years of experience in a medical device setting.
• Experience in the application of relevant standards to medical device software manufacturing, release, and post-market operations.
• Experience in working across national and cultural boundaries.
• Demonstrated capability to lead and train a large and diverse, multinational community with multiple stakeholders, working in a collaborative, coaching, mentoring and/or influencing capacity.
• Strong teamwork and communication skills to work effectively on cross-functional project teams, Interacting with a diversity of disciplines such as R&D, Quality Engineering, Regulatory Affairs, etc.
• Independent organizational and time management skills is required.
• Strong verbal and written communication skills in English.
• 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 able to work from home on a regular basis.

Preferred:

• An Advanced degree such as an MS or PhD is preferred.
• Experience in interacting with Regulatory Authorities is preferred.
• Japanese communication skill are an optional, added plus factor.

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on:

Competitive salaries, annual bonus and 401(k)* with company match

24/7 Employee Assistance Program

Free live and on-demand Wellbeing Programs

Generous Paid Vacation and Sick Time

Paid Parental Leave and Adoption Assistance*

12 Paid Holidays

On-Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace:

Work-life integrated culture that supports an employee centric mindset

Offers onsite, hybrid and field work environments

Paid volunteering and charitable donation/match programs

Employee Resource Groups

Dedicated Training Resources and Learning & Development Programs

The anticipated base pay range for this full-time position in this location is$95,904.00-$129,470.00/ year, plus potential for annual bonus(subject toplan eligibility andother requirements).

Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .

You Belong at Olympus

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish.

Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact [e-mail]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Let’s realize your potential, together.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.