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Description
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 performing and/or leading all aspects of product development, including technical planning and development strategy development, development of design inputs, and directing/supporting verification and validation efforts. In particular, it will be the responsibility of the Principal Engineer to ensure well defined product and performance specifications for the system are defined and tested to ensure all efforts are completed on schedule, while proactively mitigating potential issues, to enable the timely launch of high quality / reliable products. He or she must fully understand medical device design control requirements and be able to provide effective technical leadership to product development efforts and team members, negotiate strategies with cross-functional leaders, and work collaboratively across the organization. The Principal Engineer will serve as a core or extended team member on development projects. As they will heavily contribute to Design History Files, maintaining detailed documentation throughout all phases of research and development is essential.
The incumbent will 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 as needed.
Job Duties
* Provides technical leadership on product development projects and/or technology development efforts.
* Accountable for all aspects of product development activities and product Design History File, such as; requirements creation/documentation, ideation / prototyping, design / development, technical risk mitigation, verification testing and reports, design validation studies, risk management documentation, design reviews, and supports the compilation of documents to enable regulatory submissions.
* Develops engineering solutions, investigates competing technologies, and collaborates with Olympus Patent Attorneys to secure a strong IP portfolio
* Ideates, evaluates, and directs team towards design solutions which will meet product/performance requirements, cost targets, and manufacturability requirements.
* Accountable for the development of effective/efficient product verification and validation testing strategies, testing protocols and reports, and ensures products meets/exceed established specifications.
* Employs statistical techniques to establish exceptional product quality, reliability, and robustness.
* Consults with the Sales, Marketing, and clinicians to define and specify product user requirements and ensures product and performance specifications are appropriate and accurate.
* Manages, directs and supports internal and external suppliers and manufacturers as needed. Including external design and/or development partners.
* Helps prepare and supports marketing on, technical brochures, training programs, and technical presentations to customers and the sales force.
* Supports engineering leadership as required.
* All additional duties as directed.
Job Requirements
REQUIRED QUALIFICATIONS:
* Bachelor’s degree in Engineering required.
* Minimum of 9 years of experience, or minimum of 8 years of experience with Master’s degree, or minimum of 5 years of experience with PhD Skills/Competencies/Other considerations.
* Ability to communicate complex technical concepts clearly and concisely is required.
PREFERRED QUALIFICATIONS:
* Established track record of leading Medical Device development and/or sustaining engineering efforts utilizing a stage-gate process.
* Experience / Knowledge of single use scope systems and technologies highly 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 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).
* Must be capable of effectively directing project teams on multiple work streams in parallel and leading teams towards accomplishment of objectives.
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 ||
