Manufacturing Engineer II

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.
• Other Considerations (travel / hours availability, etc.) : Travel up to 25%, mostly Domestic.

Preferred :

• Drives Results.
• Decision Quality.
• Balance Stakeholders.
• Collaborates.
• Situational Adaptability.

Why join Olympus? We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on :

Competitive salaries, annual bonus and 401(k)* with company match

Comprehensive medical, dental, vision coverage effective on start date

24 / 7 Employee Assistance Program

Free live and on-demand Wellbeing Programs

Generous Paid Vacation and Sick Time

Paid Parental Leave and Adoption Assistance*

12 Paid Holidays

On-Site Child Daycare, Café, Fitness Center

Connected Culture you can embrace :

Work-life integrated culture that supports an employee centric mindset

Offers onsite, hybrid and field work environments

Paid volunteering and charitable donation / match programs

Diversity Equity & Inclusion Initiatives including Employee Resource Groups

Dedicated Training Resources and Learning & Development Programs

Paid Educational Assistance

US Only Center Valley, PA and Westborough, MA Are you ready to be a part of our team? . At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling.

As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

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 : Posting Notes : United States (US) Minnesota (US-MN) Brooklyn Park Manufacturing & Repair