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Principal Engineer - R&D

Req ID:  3210

Working Location: MASSACHUSETTS, WESTBOROUGH 

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 Principal Engineer is responsible for leading product development efforts as the Core Team member for R&D.  This role is responsible for leading all aspects of the product development effort and is ultimately responsible for the technical success of the program. The Principal Engineer / R&D Core Team Member will lead product development strategy and planning and ensure compliance with all applicable procedures and standards. Further, the Principal Engineer will oversee or lead concept development, prototyping and feasibility studies, establishing robust design inputs, design assessment and reliability, design advancement, development of robust Verification and Validation plans, assist in risk management efforts, and ultimately design verification and validation testing. In this role, the Principal Engineer will collaborate with other core team members to ensure alignment on development strategy, as well as direct, or oversee, the activities of extended core team members and/or development partners. The Principal Engineer is expected to drive design/concept trade-off decisions while taking costs, technical risk, reliability and User Needs into consideration. She / He must fully understand medical device design control requirements, have experience leading technical development efforts as a Core Team member, lead the product development team, and be effective at communicating to all levels of the organization.

Job Duties

*  Provides technical leadership on product development and/or technology development efforts.

 

* Envisions, collaborates/communicates, and documents detailed product development strategies while mindful of the interests of all Core Team Members.

 

* Lead product development resources, and extended team members, through a product development stage gate process from concept to launch.

 

* Routinely updates R&D manager through weekly discussions and monthly updates.  Capable of prioritizing and organizing work/efforts based on project priorities.

 

* Develops, or oversees the development of, User and Product Requirements and resulting Verification and Validation efforts to ensure the product effectively meets its requirements.

 

* Collaborates on the development of the technical development schedule and monitors advancement in collaboration with the Project Manager.   Reports advancement to Core Team and to R&D Leadership. 

 

* Accountable for all aspects of product development activities and associated deliverables, such as: Design Inputs, specification development, ideation / prototyping and feasibility testing, technical risk mitigation, verification and validation, phase specific readiness review, design reviews, compliance to applicable regulations and standards, compliance to Corporate Product Branding, etc.

 

* Directs or performs design analysis, such as tolerance stack-ups, edge of failure testing, high/low specification evaluations, risk analysis, and statistical evaluations as necessary to ensure performance and quality.

 

* Ensures product designs are developed to reduce component, assembly and material costs, as well as lead or collaborate on design for manufacturability efforts and cost reduction redesign efforts, as required. 

 

* Proactively ideates and leads technical risk reduction activities and contingency planning.

 

* Consults with the Marketing core team member and clinicians to ensure a thorough understanding of the procedure, products use, and environmental factors to ensure appropriate design decisions.

 

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

 

* Documents innovations in partnership with Olympus Patent Attorneys.

Job Requirements

REQUIRED QUALIFICATIONS

Bachelor’s degree in Mechanical Engineering or similar.

 

* Minimum of 9 years of experience; 8+ years with MS or 5+ with PhD.

 

* Competency in leading medical device technical development efforts, through all phases of product development, is required.

 

* Experience developing disposable medical devices required.

 

* Extensive working knowledge of, and experience in applying / developing products in compliance with FDA and international requirements, including 820-CFR, ISO-13485, IEC60601, QSR, etc. is required.

 

* Proficient in the creation and critical review of engineering drawings, including the ability to critique dimensioning and tolerancing strategies, is required.

 

* Knowledge of common manufacturing methods, such as; injection molding and molded part design, extrusion, adhesives, ultrasonic welding, etc., as well as experience designing/developing products employing common medical device polymers is required.

 

PREFERRED QUALIFICATIONS

Experience developing products through a Phase Gate process as a Core Team member is highly preferred.

 

* Experience and or working knowledge of developing capital equipment is desired.


* Proficient in Microsoft Windows Office applications including MS Outlook, MS Powerpoint, MS Project, Visio, etc.

 

* Working knowledge of Solidworks is a plus. 

 

* Experience in the practical application of statistics and working knowledge of a statistical analysis package (Minitab is preferred).

 

* Must be able to solve complex and/or ambiguous problems using good judgement as well as logical and systematic thinking.  Capable of providing problem solving guidance to other engineers.

 

* Must be able to envision design failure modes, plan for robust design assurance testing, and proactively implement contingency plans as necessary.

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 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) || Massachusetts (US-MA) || Westborough || 


Nearest Major Market: Worcester

Job Segment: Manufacturing Engineer, Engineer, Welding, R&D Engineer, Medical Device Engineer, Engineering, Manufacturing

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