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Principal Engineer - R&D

Req ID:  2806

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 expected to act as a technical lead on product development projects, responsible for performing and/or leading all aspects of product development including technical planning, feasibility studies, device development, verification and validation. Technical lead responsibilities may include managing the technical team and/or development partner through completion of all R&D deliverables. R&D deliverables include defining product specifications, design inputs, product design, verification testing and supporting design validation studies. The Principal Engineer is expected to make design/concept trade-off decisions taking costs, technical risk, reliability and User Needs/ergonomics into consideration. She / He must fully understand medical device design control requirements, 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 development projects. Maintains detailed planning and 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

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

 

* Create Design and Development Plan and manage all R&D deliverable activity as the R&D Core Team member.

 

* Responsible for maintaining the R&D development schedule in alignment with the PM project schedule and for reporting project status to R&D management.

 

* Accountable for all aspects of product development activities and associated deliverables such as: Design History File compilation, translation / creation and documenting of requirements, ideation / prototyping, technical risk mitigation, verification testing and reports, design validation studies, risk management documentation, design reviews, and to support the compilation of documentation to enable regulatory submissions.

 

* Develop engineering solutions, investigate competing technologies, and collaborate with Olympus Patent Attorneys to secure a strong IP portfolio.

 

* Direct or perform design analysis, such as tolerance stack-ups, strength of materials, risk analysis, and statistical evaluations.

 

* Ensure product designs are cost effective, designed for manufacturability, and exhibit a high degree of quality and reliability via well thought out [and executed] verification test plans.

 

* Consult with the Sales, Marketing, and clinicians to define and specify product user requirements; understand procedural use sufficiently to infer design decisions’ effect on product usability.

 

* Manage, direct, and support suppliers involved in product development and ongoing production. This includes outside design and/or development partners.

 

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

Job Requirements

REQUIRED QUALIFICATIONS

 

Bachelor’s degree in Mechanical Engineering, or similar.

 

* Minimum years of related experience: 9+ years with Bachelor's degree, or 8+ years with Master's degree, or 5+ with PhD.

 

PREFERRED QUALIFICATIONS

 

* Established track record of leading Medical Device development and/or sustaining engineering efforts utilizing a stage-gate process.   Experience in hand held electro-mechanical devices is preferred.
 

* Must have extensive working knowledge of, and experience in applying / developing, products in compliance with FDA and international requirements, including 820-CFR, ISO14971, IEC60601, GMP and other standards as they relate to the development and manufacture of medical devices.
 

* Capable of developing all deliverables required to document the product design with appropriate specificity to enable high volume manufacturing with high quality.
 

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

* Solidworks working knowledge.

 

* Proficient in the creation and critical review of engineering drawings, tolerancing and tolerance analysis.
 

* Knowledge of common manufacturing methodologies, technologies, and materials employed in medical devices.
 

* Ability and experienced in approaching challenging and/or ambiguous engineering problems with scientific logic and problem solving skills.   Ability to communicate complex technical concepts clearly and concisely is required. 
 

* Experience applying good judgement to make timely decisions as well as exhibit the ability to balance risk vs. benefits in a variety of situations.  
 

* Ability to effectively work within a requirements management system (e.g., JAMA, Doors) preferred.
 

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

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, Outside Sales, R&D Engineer, Medical Device Engineer, Engineering, Sales

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