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.

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