Senior Engineer, HHA

Olympus America, Inc.; False Pass (AK); Remote; USD 87,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

401(k) match

Medical coverage

Paid vacation and sick time

Parental leave

On-site daycare, cafe, fitness center

Volunteer match program

Job summary

Olympus Corporation of the Americas seeks a Health Hazard Assessment (HHA) lead to develop data-driven HHAs with robust analysis and conclusions. You will drive timely completion and ensure compliance across global operations, collaborating with Risk Management and cross-functional teams.

You will guide project teams, present to review boards, and stay current with FDA QSRs, ISO standards, and post-market activities while supporting internal and regulatory inspections.

Qualifications

• Bachelor's degree or equivalent in a technical or science-related field is required.
• Minimum of 5 years' experience in finished medical device or related regulated industry with manufacturing processes, operational excellence, quality systems, and continuous improvement activities required.
• Ability to influence across multiple sites and manage multiple projects.
• Excellent verbal and written communication skills, including public speaking and facilitation.

Responsibilities

• Leads a HHA project team to write and manage a HHA through to completion.
• Ensure HHA target completion is achieved.
• Works to meet key performance indicators.
• Prepares HHA supporting materials and presents HHA to review board as needed.
• Responds to requests for HHA amendments in a timely manner.
• Maintain knowledge of industry best practices and regulatory requirements in Risk Management, HHAs and related areas.

Skills

Cross-functional collaboration

Project management

Communication skills

Time management

Problem solving

Influencing across sites

Education

Bachelor's degree in technical or science field

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 .

Job Description

Support the development, writing and completion of Health Hazard Assessment (HHAs) across Olympus globally with focus on writing data driven, evidence based HHAs with robust issue analysis, and justified conclusions and summaries. Works to ensure HHA development and assessments occurs in a timely manner to address safety and compliance areas of our business and to ensure proper documentation are in place.

Job Duties

• Leads a HHA project team to write and manage a HHA through to completion.
• Ensure HHA target completion is achieved.
• Works to meet key performance indicators.
• Prepares HHA supporting materials and presents HHA to HHA/Field Corrective Action review board as needed.
• Responds to requests for HHA amendments in a timely manner.
• Maintain current knowledge of industry best practices and regulatory requirements as well as Olympus operations across the areas of Risk Management, HHAs and Field Actions, complaint handling, adverse event reporting, CAPA and Post Market Surveillance activities in support of HHA development and expert guidance for the HHA teams.
• Collaborates with global/regional leaders on relevant HHAs and interacts with Legal and Compliance as required.
• Supports HHA in internal and regulatory inspections.

Job Qualifications

Required:

• Bachelor's Degree or equivalent in a technical or science-related field is required.
• Minimum of 5 years' experience working in finished medical device or related regulated industry with manufacturing processes, operational excellence, quality systems, and continuous improvement activities required.
• Ability to influence across multiple sites.
• Must be self-motivated with a strong sense of urgency to solve issues.
• Ability to consistently deliver on required activities and meet assigned deadlines.
• Demonstrated ability to manage and complete multiple projects and assigned objectives.
• Prior experience leading cross-functional teams.
• Excellent verbal and written communication skills, including public speaking and facilitation.
• Excellent interpersonal skills and experience working with different personalities, cultures, and levels of management.
• Flexible working hours across multiple time zones, due to the Global nature of this role.

Preferred:

• Knowledge of Risk Management practices, Corrective and Preventative Actions and regulatory requirements such as FDA QSR's, ISO 13485, ISO 14971 & 21 CFR 820 is preferred.

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, 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
• 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 in this location is $87,185.00 - $129,700.00 / year, plus potential for annual bonus (subject to plan eligibility and other 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