Principal Engineer, Health Hazard Assessments - Remote

Req ID: 8208

Working Location: NATIONWIDE

Workplace Flexibility: Hybrid

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

We deliver on our purpose and our core values by staying True to Life.

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. This position will directly lead and/or support continuous improvement and sustaining efforts for the global processes and systems to assure compliance, harmonization, and efficiency.

Job Duties

Leads a HHA project team to create, investigate, write and manage a HHA through to completion.
Ensure HHA deadlines are achieved. Works to meet key performance indicators.
Prepares HHA supporting materials and presents HHA to Field Corrective Action review board. 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 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. Responsible for successful preparation and timely distribution of completed HHAs to the Field Corrective Action (FCA) Review Board for FCA voting.
Responsible for working in partnership with Medical Safety, Regulatory, Complaint, CAPA, and Non- Conforming teams to identify, document and escalate, where necessary, situations requiring HHA analysis. Collaborates with globaUregional leaders on relevant HHAs and interacts with Legal and Compliance as required.
Supports HHA inspections and is key internal HHA inspection leader in support of regulatory inspections.

Job Qualifications

Required:

Bachelor's Degree or equivalent in a technical or science-related field is required.
Minimum 8 years' experience working in finished medical device or related regulated industry with manufacturing processes, operational excellence, quality systems, and continuous improvement activities required.
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.
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.

Why join Olympus?

Here, people matter—our health, our happiness, and our lives.

Competitive salaries, annual bonus and 401(k)* with company match
Comprehensive Medical, Dental, Visions coverage effective on start date
24/7 Employee Assistance Program
Free virtual live and on-demand wellness classes
Work-life balance supportive culture with hybrid and remote roles
12 Paid Holidays
Educational Assistance
Parental Leave and Adoption Assistance
Volunteering and charitable donation match programs
Diversity & Inclusion Programs including Colleague Affinity Networks
On-Site Child Daycare, Café, Fitness Center**

*US Only

**Limited locations

We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks.

The anticipated base pay range for this full-time position working at this location is $128,490.00 - $179,886.00 / 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.

About us:

Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.

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.

Olympus is dedicated to building a diverse, inclusive and authentic workplace

We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.

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.

Applicants with Disabilities: As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at 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).

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

Job Segment: Medical Device Engineer, Manufacturing Engineer, CAPA, QA, Quality Assurance, Engineering, Management, Quality, Technology

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