Share this Job
Apply now »

Senior R&D Engineer

Req ID:  3216

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 Sr. Engineer will support, or lead, various efforts associated with OSTA’s product development activities under the guidance of an R&D Core Team member or R&D Manager. Under the direction of an R&D Core Team Leader, or R&D Manager, the Sr. Engineer will support, and/or lead, engineering efforts throughout OSTA’s PDP+ stage-gate development process, including: design ideation and evaluation of concepts and technologies, prototyping and feasibility testing, development and/or management of design inputs, developing product specifications and drawings, planning and conducting design evaluation studies / tests, and developing and/or executing design verification and validation testing. Within a dynamic and collaborative team environment, the Sr. Engineering will proactively manage their tasks / projects, ensure their deliverables are high quality, consistently seeks to advance their knowledge and skills, and ensure compliance to all applicable SOP’s and regulations.  Creation of technical data, data analysis, and subsequent reporting will be an important aspect of this role, as well as helping to generate all documents / deliverables that will comprise the Design History File; therefore, a working knowledge of FDA Design Controls is required.

Job Duties

* Supports the technical efforts of the Core Team (or Manager) on product development and/or technology development efforts.

 

* Contributes to product development activities and deliverables, such as; product requirements creation/documentation, ideation & prototyping, drawings and specifications, technical risk mitigation, design evaluation testing & studies, test method development, data analysis, verification and validation testing and reports, design reviews, etc.

 

* Develops product verification and validation testing strategies with a broad view of all inputs, authors testing protocols and reports, and supports testing as required. 

 

* Develops engineering solutions in partnership with R&D team to ensure alignment with product and project requirements (e.g,. cost, quality, delivery, etc.).

 

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

 

* Supports or leads design analysis efforts to ensure product performance, quality and reliability are acceptable, such as, tolerance stack-ups, edge of failure testing, minimum/maximum tolerance impact evaluations, lot-to-lot material variation impact, risk analysis, etc.

 

* Applies statistics to their work, when applicable based on risk analysis efforts, to ensure product quality.

 

* 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.

 

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

 

* Proactively ideates additional opportunities to reduce technical risk and implement contingency planning.

 

* Gains a thorough understanding of the procedure, products use, and environmental factors to ensure appropriate design decisions.

 

* Supports suppliers involved in product development and ongoing production; including external design and development partners.

 

* Documents innovations in partnership with Olympus Patent Attorneys.

Job Requirements

REQUIRED QUALIFICATIONS

Bachelor’s degree in Mechanical Engineering or similar.

 

* Minimum of 5 years or related experience, or 4+ years with MS or 3+ with PhD.

 

PREFERRED QUALIFICATIONS

Must be able to solve complicated technical challenges with creative solutions and use good judgement in making timely decisions. 

 

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

 

* Working knowledge of, and experience in applying, FDA Design Controls and international standards (e.g., Design Controls, 820-CFR, ISO14971, ISO10993, IEC60601, GMP, etc.). 

 

* Capable of developing many of the 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..

 

* Strong communication / presentation skills are necessary to provide findings at an appropriate level to team members and senior management.

 

* Solidworks working knowledge. Proficient in the creation and critical review of engineering drawings preferred.

 

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

 

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

 

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

 

* Must be capable to effectively executing on multiple work streams in parallel.

 

* Must be able to communicate effectively, both verbally and in writing.  Comfortable presenting information to team members and stakeholders.

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, R&D Engineer, Medical Device Engineer, Mechanical Engineer, Engineering

Apply now »