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 .

Statement Regarding Job Recruiting Fraud Scams

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will

never

ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and / or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https : / / vhr-otsuka.wd1.myworkdayjobs.com / en-US / External.

Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at : 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at : https : / / www.ic3.gov, or your local authorities.

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.

J-18808-Ljbffr