Vice President Device Development - San Diego California

Company: Valid8 Financial, Inc.
Location: San Diego, California
Posted On: 01/30/2025

Aspen is looking for a Vice President of Device Development to lead strategic and technical lifecycle management of the company's drug delivery devices and provide expertise in small volume cell therapy delivery. The ideal candidate has engineering expertise related to delivery devices and manufacturing automation, including development, design controls, verification/validation, technology transfer, scale-up for manufacturing, assembly processes, and human factors. As a key leader reporting to the Chief Technology Officer, this role requires demonstrated leadership, team development, communication and collaboration skills.DUTIES AND RESPONSIBILITIES:

• Lead and execute the strategy and development plan for delivery devices, collaborating with internal departments (CMC, Supply Chain, Clinical, Quality, Regulatory) and external partners (vendors, CDMOs).
• Oversee the entire lifecycle of delivery device development, from ideation and design to testing, regulatory approval, and commercialization.
• Drive the planning, execution, and delivery of automation projects within the Technical Operations function.
• Build, mentor, and lead a high-performing team of multi-disciplinary professionals to establish robust medical device and automation capabilities.
• Provide engineering leadership to cross-functional teams, ensuring collaborative execution of device development, manufacturing automation deployment, technology transfer, and ongoing manufacturing support.
• Ensure compliance of delivery devices and automation platforms with regulatory requirements and standards, including FDA, ISO, and other relevant guidelines.
• Develop and manage the budget for the device development department, ensuring efficient resource allocation.
• Identify and mitigate risks to device and automation programs, ensuring alignment with company objectives.
• Collaborate with corporate development and IP counsel to generate intellectual property and protect trade secrets critical to Aspen's drug delivery devices.
• Support product life-cycle initiatives with a focus on process optimization and cost of goods sold (COGS) reduction.
• Present technical progress, updates, and recommendations to cross-functional teams, including the Executive Management Team (EMT) and Board of Directors, while escalating issues and recommending risk mitigation strategies.EDUCATION AND EXPERIENCE:
  • BS required (MS or other advanced degree preferred) in engineering or relevant technical discipline including but not limited to biomedical engineering, mechanical engineering, or chemical/biochemical engineering.
  • A minimum of 10 years of hands-on experience in full life cycle development of medical device, or drug delivery device development and manufacturing.
  • Experience with syringes, autoinjectors, pre-filled syringes, or other combination drug delivery devices is required.
  • Experience with manufacturing automation, robotics, and/or liquid handling.
  • Experience with medical device 510k regulatory requirements, combination product validation, and regulatory market applications.
  • Demonstrated success managing and collaborating with CDMOs, design agencies, supply chain vendors and service agencies.
  • Hands-on experience working in a Manufacturing, MS&T, PD, CMC, and/or R&D function.JOB SPECIFICATIONS:
    • Communication Skills: Proficiency in executive-level presentation, communication, and interpersonal skills with good judgement to clearly convey complex issues to stakeholders.
    • Regulatory Knowledge: Familiarity with ISO standards, Quality Systems, and FDA regulations.
    • Project Management: Ability to manage multiple projects at various stages with attention to detail, effective communication, and financial stewardship.
    • Proactive: Capability to proactively operationalize goals with a commitment to quality, efficiency, and effectiveness.
    • Collaboration: Skills to develop strong working relationships, build consensus, and influence across functions.
    • Human Factors/Usability Engineering: Deep knowledge of safety, performance, and regulatory compliance for medical devices and combination products.
    • Learning Mentality: Internal drive to stay updated on current trends and emerging technologies in devices and combination products.EEO and Employment Eligibility:Aspen Neuroscience is committed to providing equal employment opportunities to all employees and job applicants and prohibits discrimination and harassment of any type. We are committed to creating an inclusive environment for all employees.Total Rewards and Culture:Aspen Neuroscience, Inc., located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need. The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, onsite gym, and other wellness perks.The anticipated salary range for candidates who will work in San Diego is $300k to $340k annually. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Aspen Neuroscience is a multi-state employer, and this salary range may not reflect positions that work in other states.
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