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Otsuka Pharmaceutical Companies (U.S.) · 1 day ago

Director, Manufacturing Engineer

Palo Alto, CA

Full-time

Onsite

Director/Executive

$222K/yr - $240K/yr

10+ years exp

Otsuka Pharmaceutical Companies (U.S.) is seeking a highly skilled and experienced Director of Engineering, Manufacturing to lead their engineering team. The ideal candidate will drive innovation, ensure regulatory compliance, and oversee the successful execution of engineering projects from concept to commercialization.

Health CareMedical

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

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

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

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

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

Prepare and manage documentation for regulatory submissions and audits

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

Manage budgets, resource allocation, and timelines for engineering projects

Establish and maintain engineering policies, standards, and procedures

Ensure adherence to safety and environmental regulations

Qualification

Medical device developmentUltrasonic therapyFDA regulationsProject managementISO 13485 standardsLeadershipCommunicationInterpersonal skillsStrategic thinkingCollaboration

Required

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

Preferred

Knowledge of ultrasonic therapy and/or PZT is a plus

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.

Company

Otsuka Pharmaceutical Companies (U.S.)

Glassdoor4.1

There are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc.

Founded in 1989

Rockville, Maryland, USA

1001-5000 employees

https://www.otsuka-us.com

H1B Sponsorship

Otsuka Pharmaceutical Companies (U.S.) has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (8)

2024 (6)

2023 (11)

2022 (5)

2021 (9)

2020 (13)