FCA Principal Engineer
Olympus Corporation of the Americas
Summary
The Principal Quality Engineer is responsible for driving complex projects to completion by effectively managing all aspects related to such initiatives within the Quality organization. Primarily focus will be on keeping technical projects organized and on track to meet defined objectives while satisfying regulatory requirements and business strategy. This position requires a global outlook and the ability to integrate many different aspects of the organization, such as functions, departments, software platforms, etc. to ensure the project satisfies various stakeholders and areas of the business.
Job description
Job Duties
- Leads and participates in cross-technical solution initiatives, such as defining scope, establishing an appropriate cross-functional team, planning, driving issues to resolution, escalating and mitigating risks, tracking, and reporting.
- Provides expertise in the application of Quality Sciences including statistics, data analysis, problem solving and the creation of system solutions.
- Defines actionable KPIs that influence the organization's directions, identifies gaps, current limitations, and challenges.
- Develops interactive dashboard and report for appropriate stakeholders.
- Interfaces, collaborates, and/or serves as a liaison with cross-functional teams, such as IT, Engineering, Operations, Finance, Security, Analytics, Legal, Comms, PMO, etc.
- Evaluates current state business processes and identify opportunities for increasing efficiency, reducing cost, etc. and quantify the problem through solution.
- Designs, builds, manages, and coordinates innovative solutions through low code/no code solutions, cloud based platforms, process automation tools, M365 & Power Platform, ERP, APIs, and any other newer technologies that may benefit the organization.
- Translates business use cases into technical specifications.
- Serves as a Subject matter expert (SME) for M365 productivity tools: PowerApps, Power BI, Power Automate, SharePoint.
- Effectively influences project team through written and verbal communication.
- Performs other duties as assigned.
Job Qualifications
- Bachelor's degree in business administration, health policy, life sciences, engineering, or healthcare discipline.
- MBA or similar advanced degree preferred.
- Minimum 10 years leading projects with a focus on process improvement and data analytics.
- Proven ability to lead and manage cross-functional teams effectively communicate with all levels of management and drive effective change.
- Requires background and familiarity with U.S. FDA QSR requirements including ISO 13485 and the ability to educate others on related subject matter.
- Strong Quality Science skills including demonstrated statistics application and problem solving.
- Excellent verbal and written communication skills demonstrated by ability to generate technical reports and ability to make presentations to middle and upper management.
- Proven Project Management skills with ability to manage cross functional team and produce results.
- Strong Interpersonal Skills, Ability to manage complexity, analytical, people management on a global basis, office 365.
- Ability to travel up to 20% of time domestically and internationally.
Requirements
- Bachelor's degree in business administration, health policy, life sciences, engineering, or healthcare discipline
- MBA or similar advanced degree preferred
- Minimum 10 years leading projects with a focus on process improvement and data analytics
- Proven ability to lead and manage cross-functional teams and communicate with all levels of management
- Background and familiarity with U.S. FDA QSR requirements including ISO 13485
- Strong Quality Science skills including statistics application and problem solving
- Excellent verbal and written communication skills
- Proven Project Management skills
- Strong interpersonal skills and ability to manage complexity
- Office 365 proficiency
- Ability to travel up to 20% domestically and internationally
Benefits
- Competitive Salaries
- Annual Bonus
- 401(k) Matching
- Medical, Dental & Vision
- Employee Assistance Program
- Wellbeing Programs
- Paid Vacation & Sick Time
- Paid Parental Leave
- Adoption Assistance
- 12 Paid Holidays
- On-Site Child Daycare
- Café
- Fitness Center
- Paid Volunteering
- Charitable Donation Match
- Employee Resource Groups
- Educational Assistance
Company overview
Olympus Corporation of the Americas is a leading global medical technology company and a wholly owned subsidiary of Olympus Corporation, headquartered in Center Valley, Pennsylvania. As a pioneer in the medical device industry, Olympus specializes in developing and manufacturing advanced endoscopic solutions, minimally invasive surgical equipment, and diagnostic imaging systems. The company holds approximately 70% of the global endoscope market, with a comprehensive portfolio that includes gastrointestinal endoscopes, laparoscopes, bronchoscopes, urological devices, and video imaging platforms. With over 5,200 employees across North and South America, Olympus focuses on creating innovative medical technologies that enable early detection, diagnosis, and minimally invasive treatment of diseases. The company's products are used across multiple medical specialties including gastroenterology, pulmonology, urology, and general surgery, helping healthcare professionals improve clinical outcomes while reducing procedural costs. Olympus continues to invest heavily in research and development, digital healthcare solutions, and AI-powered diagnostic tools to maintain its leadership position in the medical technology sector.