Senior Engineer, HHA

About the role

Support the development, writing and completion of Health Hazard Assessments (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 occur in a timely manner to address safety and compliance areas of our business and to ensure proper documentation are in place.

Responsibilities

• Leads a HHA project team to write and manage a HHA through to completion.
• Ensures 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.

Requirements

• 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.
• Self-motivated with a strong sense of urgency to solve issues.
• Able 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.

Qualifications

• 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.

Skills

• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to work independently and as part of a team.
• Experience with regulatory compliance and risk management.

Benefits

• Competitive salaries, annual bonus and 401(k) with company match.
• Comprehensive medical, dental, vision coverage effective on start date.
• 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.

Pay

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).

Schedule

Flexible working hours across multiple time zones, due to the Global nature of this role.