Director, Manufacturing Engineer

Position Overview : We are seeking a highly skilled and experienced Director of Engineering, Manufacturing to lead our engineering team. The ideal candidate will have a strong background in medical devices, including both hardware and consumables expertise. Knowledge of ultrasonic therapy and / or PZT is a plus. This role requires a visionary leader who can drive innovation, ensure regulatory compliance, and oversee the successful execution of engineering projects from concept to commercialization.

Key Responsibilities :

Leadership & Management :

Lead and mentor a team of engineers, fostering a culture of innovation and excellence.

Oversee the hiring, training, and development of engineering staff.

Conduct performance evaluations and provide constructive feedback.

Project Management :

Plan, coordinate, and supervise engineering projects within the organization.

Ensure projects are completed on time, within budget, and meet quality standards.

Collaborate with cross-functional teams, including R&D, regulatory, and manufacturing, to align engineering efforts with company objectives.

Technical Expertise :

Provide technical guidance and support in the development of ultrasonic therapy devices for renal denervation.

Stay abreast of the latest advancements in medical device technology and integrate new innovations into product development.

Regulatory Compliance :

Ensure all engineering activities comply with FDA regulations and ISO 13485 standards.

Prepare and manage documentation for regulatory submissions and audits.

Strategic Planning :

Develop and implement engineering strategies that align with the company's long-term goals.

Manage budgets, resource allocation, and timelines for engineering projects.

Quality Assurance :

Establish and maintain engineering policies, standards, and procedures.

Ensure adherence to safety and environmental regulations.

Qualifications :

Bachelor's or Master's degree in Engineering, Biomedical Engineering, or a related field.

Minimum of 10 years of experience in medical device development, with at least 5 years in a leadership role.

Proven track record of successful project management and product development in the medical device industry.

In-depth knowledge of ultrasonic therapy and renal denervation technologies.

Strong understanding of FDA regulations and ISO 13485 standards.

Excellent leadership, communication, and interpersonal skills.

Ability to work collaboratively in a fast‑paced, dynamic environment.

Benefits :

Competitive salary and performance‑based bonuses.

Comprehensive health, dental, and vision insurance.

Retirement savings plan with company match.

Opportunities for professional development and career advancement.

Salary Range : $221,695- $240,000 (Annual Base Salary)

Competencies

• Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
• Strategic Thinking & Problem Solving - Make decisions considering the long‑term impact to customers, patients, employees, and the business.
• Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and / or key stakeholders.
• Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
• Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
• Empowered Development - Play an active role in professional development as a business imperative.

Come discover more about Otsuka and our benefit offerings; https : / / www.otsuka-us.com / careers-join-otsuka.

Disclaimer :

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer . All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic .

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability . You can request reasonable accommodations by contacting Accommodation Request .

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Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre‑existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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