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Manufacturing Engineer II

3 months ago

Westborough, Massachusetts, United States Olympus Corporation of the Americas Full time

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.

**Please note: All correspondence will be sent from our Olympus domain ). If you receive correspondence from an entity other than , it is likely not legitimate.

Job Description

The position holder is responsible for the execution and documentation of process development deliverables and activities for Single Use Endoscopes (SUE) product development and launch to production. The position holder 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 responsible for proactive engineering responses in alignment with Regulatory compliance requirements.

Job Duties

  • Complete process development activities under the guidance and leadership of senior engineers to meet project goals including process characterization and optimization, prototype development, process validation, pilot build, process control and product release readiness
  • Ensure outstanding product development processes including FDA compliance and alignment to the Phase Gate product development process
  • Execute studies to understand and optimize processes (e.g. design of experiments)
  • Responsible for the development and validation of capable production and test processes that meet operational objectives as assigned
  • Authors test protocols and reports and related technical documentation in accordance with good documentation practices to ensure that studies and tests are in executed in an effective and compliant manner.
  • Executes process validation and test method validation activities with statistically relevant and robust methods.
  • Contribute to process risk analysis and control systems development and implementation.
  • Partner with industrial engineering and manufacturing peers to ensure that processes developed are suitably industrialized and able to be effective at commercial scale.
  • Works with other functions to standardize, leverage and implement engineering tools and establish best-demonstrated practices
  • Provides Process Engineering support all necessary projects and activities
  • Execute 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 Physics, or a related field
  • Minimum years of experience: 2+ years with a bachelors, 0+ with a masters, working in a manufacturing engineering or related role. Experience working in a regulated medical device environment is a strong plus.
  • Experience working in a team setting bringing processes from development through validation.
  • Expertise with the development of processes and related documentation. Strong good documentation practices (GDP) are required.
  • Working knowledge of some or all core manufacturing 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
  • Travel up to 25%, mostly Domestic

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 .

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 .

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.

Applicants with Disabilities: As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus

Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Manufacturing & Repair