Senior Engineer, HHA

Olympus Corporation of the Americas; Center Valley (Lehigh County); On-site; USD 87,185 - 129,700; Full time

Benefits offered by this job

Competitive salary

Annual bonus

401(k) with company match

Wellbeing programs

Paid vacation and sick time

Parental leave and adoption assistance

Paid holidays

On-site daycare, café, fitness center

Job summary

Olympus Corporation of the Americas is seeking a Health Hazard Assessment (HHA) lead within Quality & Regulatory Affairs in Center Valley, PA. The role focuses on developing data-driven HHAs across the organization, ensuring timely completion and regulatory alignment.

You will collaborate with global teams, manage cross-functional projects, and support inspections. A technical degree and at least 5 years in regulated medical device industry are required.

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.
• 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.

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 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.

Skills

Bachelor's Degree

5+ years experience

Cross-functional leadership

Public speaking

Written communication

Time management

Problem solving

Education

Bachelor’s Degree or equivalent in a technical or science-related field

Job description

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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.

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.

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 $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 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 [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.

Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley ||Quality & Regulatory Affairs (QA/RA)