Director, Design Assurance (Japan based)

Director, Design Assurance (Japan based) Working Location: Massachusetts, Westborough Workplace Flexibility: Remote Quality leader providing strategy, execution, oversight, training and mentoring to the organization for new product development, sustaining/lifecycle engineering, risk management and end‑to‑end product quality. Directly responsible for the Sustaining Design Assurance Organization in Hachioji (Ishikawa) Japan, with potential indirect reports in Hyderabad, India as deemed appropriate based on business needs. This includes Product Development Quality Engineering, Risk Management, and CAPA engineers. Job Duties Mentors and leads the Hachioji, Japan Sustaining Design Assurance Engineering staff supporting new product development and sustaining engineering projects across GI, GI‑ET, and GI‑EUS products. Championship and subject‑matter expert for customer and patient‑focused end‑to‑end Risk Management. Supports all aspects of the product lifecycle for products in scope, including sustaining activities, design change management, complaint investigations and ongoing risk management activities/post‑market surveillance. Supports facility audits by outside agencies (i.e., FDA, ISO / MDSAP) and acts as a subject‑matter expert to demonstrate compliance with regulatory requirements and the Olympus Quality System. Stakeholder and collaborator with senior management relating to project, process, business, and quality decisions. Supports EUMDR and other state‑of‑the‑art regulatory standard requirements. Support for Hachioji quality records, including but not limited to CAPAs, nonconformances, post‑market risk assessments, HHA, and relevant internal and external audit findings. Other quality responsibilities, delegations and special projects as assigned by Management. Job Requirements Required: BS degree or equivalent in engineering or life science discipline. Minimum of 10‑15 years of professional experience or equivalent training or equivalent education in quality or other engineering discipline. Minimum of 5 years working in medical device new product development management position(s) and people leadership. Proven track record in the global execution of New Product Development delivering on robust, customer and patient‑focused product quality, concept through post‑launch for worldwide markets. Strong technical skills related to Design Assurance including VOC translation to Design Inputs and Outputs, Human Factors, CTQ cascades, design characterization, verification/validation, test method validation, process validation, inspection techniques and statistics. Ability to drive value and product differentiation through the Design Assurance Team. Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the MedTech industry (e.g., ISO, QSR, GMP, GLP, GCP, HIPAA, Design Controls, Human Factors, Risk Management practices). Strong working knowledge of technical problem‑solving skills. Strong collaboration and influencing skills and the ability to work across functions. Must be a change agent, highly and effectively organized, be a flexible self‑starter, team‑oriented and excellent at prioritization and multitasking. Strong track record of product and process continuous improvement is required. A self‑starter motivated and able to positively motivate others. Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside Olympus. Focused, target‑driven with a positive attitude and a desire to improve patient and customer experience as well as company performance. This role is an expat position that requires a candidate to relocate to Japan for a 2 to 3 year assignment and includes up to 10% domestic travel. Preferred: MBA or other advanced degree strongly preferred. Design or Process Black Belt is a plus. Strong working knowledge of six sigma methodologies is a plus. Equitable Offerings you can count on Competitive salaries, annual bonus and 401(k) with company match. 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. Employee Resource Groups. Dedicated training resources and learning & development programs. The anticipated base pay range for this full‑time position is $154,866.00–$216,812.00 per year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the national average of the range and may vary depending on the location of the individual. Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact View email address on click.appcast.io. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus View phone number on click.appcast.io). 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. #J-18808-Ljbffr