Remote For more than 100 years, Olympus has focused on making people's lives healthier, safer and ... Minimum of 6 years of experience in a medical device setting. * Experience in the application of ...
Remote For more than 100 years, Olympus has focused on making people's lives healthier, safer and ... Minimum of 6 years of experience in a medical device setting. * Experience in the application of ...
Experience with medical device software development is preferred, but not required ZOLL Medical ... For fully remote positions, compensation will comply with all applicable federal, state, and local ...
Experience with medical device software development is preferred, but not required ZOLL Medical ... For fully remote positions, compensation will comply with all applicable federal, state, and local ...
Remote For more than 100 years, Olympus has focused on making people's lives healthier, safer and ... Minimum of 6 years of experience in a medical device setting. * Experience in the application of ...
Remote For more than 100 years, Olympus has focused on making people's lives healthier, safer and ... Minimum of 6 years of experience in a medical device setting. * Experience in the application of ...
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Remote Medical Device Software Engineer information
See Boston, MA salary details
$69K - $83K
2% of jobs
$83K - $97K
4% of jobs
$97K - $111.1K
6% of jobs
$111.1K - $125.1K
8% of jobs
$132.6K is the 25th percentile. Wages below this are outliers.
$125.1K - $139.1K
7% of jobs
$139.1K - $153.1K
18% of jobs
The median wage is $156.4K / yr.
$153.1K - $167.2K
16% of jobs
$167.2K - $181.2K
2% of jobs
$186.9K is the 75th percentile. Wages above this are outliers.
$181.2K - $195.2K
26% of jobs
$195.2K - $209.2K
1% of jobs
$209.2K - $223.3K
8% of jobs
$69K
$160.3K
$223.3K
How much do remote medical device software engineer jobs pay per year?
What are some common challenges faced by Remote Medical Device Software Engineers, and how can they be addressed?
What does a Remote Medical Device Software Engineer do?
What are the key skills and qualifications needed to thrive as a Remote Medical Device Software Engineer, and why are they important?

Principal Engineer, Design Quality - Software
Westborough, MA • On-site, Remote
Other
Medical, Dental, Vision, Retirement, PTO
Posted 29 days ago
Olympus Corporation Of The Americas rating
7.9
Based on 18 frontline employees who took The Breakroom Quiz
169th of 430 rated machine equipment manufacturers
Job description
Working Location: Nationwide
Workplace Flexibility: Remote
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 of patient 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.
Learn more about Life at Olympus: https://www.olympusamerica.com/careers.
This role provides professional expertise for Software quality 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 Olympus 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 proof of concept. This individual must work with product management, business units, engineering product owners and software architects to define feasible product requirements. This individual is 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.
- Advise SW development teams on Software development processes and practices (SiMD/SaMD/Health SW/Cloud). Advise SW development teams on architecture in the context of regulatory impact, safety, security and best practices.
- Investigate and implement harmonization of SW processes across different Olympus legal entities.
- Advise Olympus 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, cloud infrastructure, and validation best practices.
- Collaborate on the update of SDLC and operations processes and activities for the inclusion of security-by-design and privacy-by-design in SW development.
- Collaborate with development teams on applying Agile development practices for continuous rapid product delivery while maintaining compliance and quality.
- Provide project management oversight for QMS integration, Quality plans, process updates, and training.
- Represent Olympus's SW development QMS during inspections and audits.
- Perform capability audits of software projects.
- Establish and monitor performance metrics for SW development activities.
- Support the establishment of a response framework for queries and audit findings related 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 related activities
Required:
- Undergraduate (BS) Degree in engineering, computer science, life sciences, or other related degree eld. An Advanced degree such as an MS or PhD is preferred.
- Minimum of 9 years of experience in the eld 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 lead and train a large and diverse, multinational community with multiple stakeholders, working in a collaborative, coaching, mentoring and/or inuencing capacity.
- Strong teamwork and communication skills to work eectively 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; German and/or Japanese is a plus.
- Will work with global teams; availability will include working across the associated time zones; some exibility 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.
Why join Olympus?
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
Comprehensive medical, dental, vision coverage effective on start date
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, Cafe, 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
Paid Educational Assistance
*US Only
**Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?
Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.
The anticipated base pay range for this full-time position is $119,670.00 - $167,538.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range, and may vary depending on the location of the individual.
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. We warmly encourage all who wish to bring their talents to Olympus to apply.
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 OCAAccommodations@olympus.com. 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.
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)
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About Olympus Corporation of the Americas
Sourced by ZipRecruiter
Industry
Medical equipment and supplies manufacturing
Company size
10,000+ Employees
Headquarters location
Center Valley, PA, US
Year founded
1968