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Principal Engineer - Manufacturing

Olympus Medical Systems

Olympus Medical Systems

Westborough, MA, USA
Posted on Thursday, February 22, 2024

Working Location: MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK

Workplace Flexibility: Onsite

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

We deliver on our purpose and our core values by staying True to Life.

Job Description

The position holder is responsible for the execution of process development deliverables and activities for Single Use Endoscopes (SUE) product development and launch to production. The position holder develops, improves, and implements the optimal manufacturing processes according to product delivery, operations, and business requirements to launch products effectively, on time, with high reliability and the right cost.
The position holder engages with cross functional development team (e.g. R&D, QA, etc) to influence and be influenced to ensure that operational and project goals and risks are balanced and managed proactively.
The position holder responsible for proactive engineering responses in alignment with Regulatory compliance requirements.

Job Duties

  • Establish plans and complete process development activities to meet project goals including specification development, technology selection, process optimization, design for manufacturing evaluations, design reviews, prototype development, pilot build and product release readiness
  • Ensure outstanding product development processes including FDA compliance and alignment to the phase gate product development process.
  • Align with equipment engineering, industrial engineering, and production teams to ensure alignment and cohesiveness in overall process design and implementation to meet business, operational, and project needs
  • Contribute to project status reporting, proactively identifying, resolving, and presenting any issues that may impact the team’s ability to meet key goals
  • Evaluate and deploy cutting edge state of the art manufacturing methodologies to improve reliability, efficiency and cost metrics.
  • Explore, evaluate, and implement optimal technologies and processing methodologies to improve quality and reliability and to reduce manufacturing cost. Cater technical solutions and process design to the product attributes (e.g. volume, reliability, cost targets)
  • Serve as the “voice of the process” in cross functional project teams, ensuring that manufacturing process is adapted to product design requirements and vice-versa. Ensures that the evolution of product and process maintain in lock step through the development process.
  • Contributes to the broader manufacturing strategy for products (e.g. make-buy, network strategy decisions, process modalities and automation, etc).
  • Reviews technical deliverables, protocols, and reports from junior engineers as needed to provide technical coaching and ensuring top level technical rigor.
  • Evaluate all available internal and external Operational SUE Product launches including manufacturing equipment, and Materials. Select and implement appropriate technologies that result in lower manufacturing cost, lower process variability and higher manufacturing capability.
  • Provides Process Engineering in support all necessary projects and activities
  • Own and drive process capabilities, and risk documentation for project assigned
  • All Other Essential Duties as directed.

Job Qualifications

Required:

  • B.S. degree in Engineering or a related field.
  • An advanced degree (M.S.,PhD or MBA) is preferred.
  • Minimum of 9+years of industry experience with a proven track record of successful product development within a regulated product development environment.
  • Minimum of 8+ years with advanced degree (MS or MBA). 5+ years with PhD.
  • Other Considerations (travel/hours availability, etc.): Travel up to 25%, mostly Domestic.

Preferred:

  • Experience working in a multidisciplinary team setting bringing products from conception through market release and beyond. A record of commercialized products for volume production is required.
  • Expertise with the development of processes, documentation, and execution of electro-mechanical medical device process development and validation is required.
  • Experience partnering with external suppliers for the development of new processes and technologies as demonstrated with commercialized products.
  • Able to think both logically and creatively and possess sound reporting abilities.
  • Advanced knowledge of core engineering tools. For example: 6-sigma, FMEA, Risk Analysis, Process Mapping, Standard Work Instructions, Lean Manufacturing, Manufacturing Work Instruction Creation, DOE methods, Process Characterization, Verification & Validation activities.
  • Advanced technical expertise in one or more sub-specialties of process engineering (e.g. injection molding, extrusion, vision systems, PCBA, CAD, stamping, machining, additive manufacturing, etc).
  • Knowledge of and experience with financial elements of process engineering (e.g. cost modelling, cost structure optimization).
  • Experience in planning and executing process characterization and validations studies.
  • Experience in planning and implementing process control systems.
  • Experience test method development and validation.

Why join Olympus?

Here, people matter—our health, our happiness, and our lives.

  • Competitive salaries, annual bonus and 401(k)* with company match
  • Comprehensive Medical, Dental, Visions coverage effective on start date
  • 24/7 Employee Assistance Program
  • Free virtual live and on-demand wellness classes
  • Work-life balance supportive culture with hybrid and remote roles
  • 12 Paid Holidays
  • Educational Assistance
  • Parental Leave and Adoption Assistance
  • Volunteering and charitable donation match programs
  • Diversity & Inclusion Programs including Colleague Affinity Networks
  • On-Site Child Daycare, Café, Fitness Center**

*US Only

**Limited locations

We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks.

About us:

Our 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 costs, and enhance the quality of life for patients and their safety.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.

Olympus is dedicated to building a diverse, inclusive and authentic workplace

We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.

Let’s realize your potential, together.

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 || Manufacturing & Repair