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Olympus Corporation of the Americas Senior R&D Manager in Westborough, Massachusetts

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 Senior Manager of Research and Development will be responsible for leading R&D Engineering resources at OSTA’s Westborough facility, as well as playing a large role in product and technology development efforts. As a functional leader and contributor, the Sr. Mgr. will ensure R&D programs are developed in compliance to all applicable internal SOP’s and regulations, and in line with organizational Quality, Business, Cost and Delivery (QBDC) expectations.

The Sr. Mgr. will oversee and guide all aspects of the product development and/or technology development efforts under their purview, and ultimately shares responsibility for the technical success of the program with their R&D Core Team Member. The Sr. Mgr. will oversee product development strategies and planning, execution of deliverables, and partner with cross-functional peers to seek continuous improvement, as well as partner with business leaders to collaborate on product ideas and development strategies to bring their products forward.

The Sr. Mgr. must be expert in the product development of disposable medical devices and working knowledge and experience overseeing the development of systems. Must be capable of leading and mentoring a staff of engineers.

Job Duties

  • Direct supervisory responsibility for engineering resources.

  • Routinely updates R&D leadership through weekly discussions and monthly updates. Capable of prioritizing and organizing work/efforts based on a global view of priorities.

  • Plans for and assigns engineering resources as applicable with insight from R&D leadership.

  • Ability to function as a Core Team Member on product and technology development projects and leads R&D efforts in support of core team milestones.

  • Participates in regular meetings with project teams to resolve issues and risks, to maintain R&D staff engagement/focus, and to communicate technical development updates and plans with all team members.

  • Collaborates with project managers to foresee/understand critical project activities and to enable them to manage team resources and tasks to avoid critical path slippage.

  • Monitors the execution of project activities and deliverables, such as; development of robust design inputs, concept / prototyping, feasibility testing, design analysis, design verification and validation strategies, etc.

  • Oversees the quality of the deliverables produced by their team and provides mentoring where appropriate.

  • Actively monitors technical and project risks and implements contingency plans where appropriate.

  • Mentors team members as necessary, as well as champions any training and/or tools necessary to create a consistent approach to all programs and efforts (assists in building a high performing culture).

  • Establishes and fosters relationships with internal and external partners, establishes trust, and supports cross-functional peers as appropriate.

  • Supports and seeks continuous improvements to OSTA’s product development process and deliverables.

  • Ensures the decisions and actions of their team, and themself, is consistent with OSTA’s Quality, Business, Cost, and Delivery expectations.

  • Consults with the Marketing peers and clinicians to ensure a thorough understanding of applicable procedures, products usage, and environmental factors to ensure appropriate design decisions.

  • Assists or Leads project estimation activities.

  • Recruits staff, develops them through assignments, guidance, and mentorship, and manages their performance.

  • Performs all other duties as assigned.

Job Requirements

REQUIRED QUALIFICATIONS

* Bachelor’s degrees in Mechanical, Biomedical, Polymer, or related engineering disciplines.

  • Minimum of 12 years of experience in medical device product development.

  • Minimm of 7 years managing projects or as an R&D Core Team Member.

  • Minimum of 3 years managing R&D engineering resources.

  • Must have extensive working knowledge and application of FDA requirements, including 820CFR, ISO-13485, ISO14971, ISO-10993, IEC60601, as well as other standards as they relate to the design, development and manufacture of medical devices.

PREFERRED QUALIFICATIONS

  • Capable of ensuring high quality work product, proactive solution generation, high productivity, and continuous improvement.

  • Expertise in FDA Design Controls and development of medical devices.

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

  • Proficient in requirements management.

  • Experience managing external development partners.

  • Capable of building strong relationships with internal customers, maintains awareness of their needs, responds promptly to all requests, and appropriately manages expectations.

  • Must be capable of effectively managing internal and external resources in light of varying priorities and responsibilities without over-committing.

  • Capable of leading teams through ambiguous or challenging product development situations with consideration of the viewpoints / concerns of all stakeholders.

  • Experienced in applying good judgement and making timely decisions while considerate of technical/business risks in a variety of situations.

  • 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 ||

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