Working Location: MASSACHUSETTS, WESTBOROUGH
Workplace Flexibility: Hybrid
For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy. Job DescriptionThe 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 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 is responsible for proactive engineering responses in alignment with Regulatory compliance requirements.
Job DutiesComplete 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 executed in an effective and compliant manner.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).Execute 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.Work with other functions to standardize, leverage and implement engineering tools and establish best-demonstrated practices.Provide Process Engineering support for all necessary projects and activities.Execute and drive process capabilities, and risk documentation for projects assigned.All Other Essential Duties as directed.Job QualificationRequired: B.S. degree in Engineering or Physics, or a related field.Minimum years of experience: 5+ years with a bachelor's, 4+ with a master's, 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,Situational Adaptability.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 match24/7 Employee Assistance ProgramFree live and on-demand Wellbeing ProgramsGenerous Paid Vacation and Sick TimePaid Parental Leave and Adoption Assistance*12 Paid HolidaysOn-Site Child Daycare, Café, Fitness Center**Connected Culture you can embrace: Work-life integrated culture that supports an employee centric mindsetOffers onsite, hybrid and field work environmentsPaid volunteering and charitable donation/match programsDiversity Equity & Inclusion Initiatives including Employee Resource GroupsDedicated Training Resources and Learning & Development ProgramsAt 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.
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
#J-18808-Ljbffr
