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Director, Manufacturing Engineer
Director, Manufacturing EngineerOtsuka Pharmaceutical Co., Ltd • Palo Alto, CA, US
Director, Manufacturing Engineer

Director, Manufacturing Engineer

Otsuka Pharmaceutical Co., Ltd • Palo Alto, CA, US
[job_card.variable_days_ago]
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  • [job_card.full_time]
[job_card.job_description]

Director, Engineering page is loaded## Director, Engineeringremote type : Onsitelocations : Palo Altotime type : Full timeposted on : Posted 2 Days Agojob requisition id : R10061At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise uRDN System, we're on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe. Position Overview : We are seeking a highly skilled and experienced Director of Engineering 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) The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions. Equal Employment Opportunity At Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.Respecting your privacy is an essential part of the Company's privacy program and we are committed to the proper handling of Personal Information collected or processed in connection with an Applicant's application for employment, a Contract Worker's work, or a Former Employee's employment at Recor. Refer to our for more detail information.

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