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Senior Principal Product Development Engineer

Req ID:  5202

Working Location: Missouri, St. Louis 

 

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. 
 
Let’s inspire healthier lives, together.

Job Description

The Senior Principal Product Development is responsible for all aspects of product development including performing technical planning, device integration, verification, and validation. The major responsibilities of the position are performing and overseeing others perform activities such as defining product specifications, design inputs, product design, verification testing and supporting design validation studies. Evaluates alternatives including cost and risk, supportability, and analyses for total device. He or she must fully understand medical device design control requirements and be able to effectively manage a product development project and work effectively in a cross functional team.  May serve as a core or extended team member on PRP/NPD projects. Conducts feasibility studies of the design to determine ability to function as intended. Maintains detailed documentation throughout all phases of research and development.

 

May provide leadership and direction to Engineering Technicians and mentor less experienced engineers within and across OSTA sites in best practices for the use of engineering tools and methods.

Job Duties

* Providing expertise and guidance to Olympus Engineers, Marketing, Manufacturing, and Management

 

* Project leader on Exploratory, Discovery, TRP and TDP Projects

 

* Represents Olympus and presents technical data at industry trade shows

 

* Extensive technical expertise from concept through production 

 

* Owns all aspects of product development activities, such as prototyping, verification testing, design validation studies; risk documentation, design reviews, and documentation compilation for regulatory requirements

 

* Develops engineering solutions, investigate competing technologies, research the patent landscape, and protect engineering solutions by filing invention disclosures.

 

* Responsible for the design and development of new products.

 

* Responsible for planning, scheduling, and executing all assigned projects.

 

* Consults with the Sales, Marketing, and clinicians to facilitate proper design of new or modified products.

 

* Manages, directs and supports vendors involved in product development and ongoing production.

 

* Prepares and acts as a consultant to marketing on technical brochures, training programs, and technical presentations to customers and the sales force

 

* Conducts testing and collects the necessary product data to support the Value Analysis Committee Materials

 

* Designs various aspects of medical devices with a focus on design for manufacturability, ergonomics and COGS.

 

* Works directly with Marketing to define and specify new product user requirements, design inputs for medical devices.

 

* Develops product verification and validation testing requirements, testing protocols and testing reports to ensure products meet specification.

 

* Acts as a consultant, as needed, to other departments, customers, and upstream marketing.

 

* Investigates and solve critical production product/process problems on demand. 

 

* Perform design analysis, e.g. tolerance stack-ups, strength of materials (factor of safety), FEA risk analysis, etc. required for new and existing products.

 

* Working knowledge of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP and other standards as they relate to the design and manufacture of medical devices.

 

* All Other Essential Duties as directed.

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor’s degree in Engineering or the equivalent in years of industry experience.

 

* Minimum years of related experience: 14 years with BS; 10 with MS; 8 with PhD.

 

* Must have working knowledge of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP and other standards as they relate to the design and manufacture of medical devices.

 

PREFERRED QUALIFIATIONS:

 

* Experience in statistical analysis package (Stat Ease, Minitab), preferred.

 

* Proficient with the creation and critical review of engineering drawing and specification documentation.

 

* Proficient in Geometric dimensioning and tolerance.

 

* Proficient in Microsoft Windows environment, Outlook, excel, MS project, 3D CAD/CAM software 

 

* Must be able to solve complex problems and provide guidance to other engineers.

 

* Must be able to work with ambiguity and uses good judgement in making decisions. Able to balance risk and opportunities.

 

* Must be able to collaborate effectively with all levels, works well within cross-functional teams and across multiple sites, as applicable. 

 

* Must be able to manage resources and drives for results, effectively managing projects and timelines.

 

* Must be able to communicate effectively at all levels, both verbally and in writing. Has strong presentations skills and the ability to influence.

 

* Inspires and motivates others and may provide work direction.

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.

 

Olympus requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.

 

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

 

Olympus’ 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 overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.

 

Olympus…True To You. True To Society. True To LIFE.

 

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) || Missouri (US-MO) || St. Louis || 


Nearest Major Market: St Louis

Job Segment: R&D Engineer, Developer, Testing, Manufacturing Engineer, Medical Device Engineer, Engineering, Technology

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