Olympus Corporation of the Americas · 2 days ago

Senior Engineer, Health Hazard Assessment

Center Valley, PA

Full-time

Remote

Senior Level

$83K/yr - $112K/yr

3+ years exp

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Medical Device

Insider Connection @Olympus Corporation of the Americas

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Responsibilities

Support the development, writing, and completion of Health Hazard Assessment (HHAs) across Olympus globally.

Lead a HHA project team to write and manage HHAs through to completion.

Ensure HHA target completion is achieved and meet key performance indicators.

Prepare HHA supporting materials and present HHAs to review boards as needed.

Maintain current knowledge of industry best practices, regulatory requirements, and Olympus operations.

Collaborate with global/regional leaders and interact with Legal and Compliance.

Support HHAs in internal and regulatory inspections.

Qualification

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Manufacturing ProcessesQuality SystemsContinuous ImprovementFlexibilityRisk ManagementPreventative ActionsFDA QSRsISO 13485ISO 1497121 CFR 820Problem-SolvingInfluenceSelf-MotivatedSense of UrgencyTime ManagementProject ManagementTeam LeadershipVerbal CommunicationWritten CommunicationPublic SpeakingFacilitationInterpersonal Skills

Required

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

Minimum 3 to 5 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.