AGILE Product Development (APD) is a contract services firm specializing in early-stage development and pilot line manufacturing of interventional medical devices. The Manager of AGILE Product Development oversees all aspects of their assigned APD site to ensure that activities of the company are performed at a high standard of technical delivery, customer service, and financial performance. A suitable candidate should be experienced in cross-functional team leadership that facilitates effective collaboration between Product Development (PD), New Product Introduction (NPI), and Quality Assurance (QA).

An individual well-suited to this role will have experience in the full product development lifecycle including early-stage concept generation, project scoping and budget definition, detailed schedule and task management, Design Verification planning and execution, and manufacturing process development in low volume / high mix environments. As a supervisory resource, the AGILE Product Development Manager is expected to establish best practices, identify and implement necessary training for the team, and resolve complex technical and business challenges using formal engineering rigor and data driven decision making.

This individual must work closely with the Resonetics commercial team to maintain a healthy opportunity pipeline that ensures effective forecasting and resource planning across the site, including timely completion of proposals and participation in marketing / new business development initiatives.

As a key stakeholder in cross-site and inter-department collaboration, the Manager of AGILE Product Development is expected to build strong relationships throughout Resonetics and act as an effective liaison with the LIGHTSPEED and Operations teams. Additionally, this individual must interact with consultants, clients, suppliers, and other external resources to communicate and implement company objectives in accordance with the QMS while ensuring compliance with applicable standards and regulations.

• Plan and execute against site level budget, strategic objectives, resource plan, and commercial forecast.
• Provide technical program management oversight, guidance, and troubleshooting on product development programs ranging in scope from discrete development activities to full multi-phase projects.
• Supervise staff across all disciplines within AGILE, including Product Development (Engineers, R&D Technicians, and Co-Ops), New Product Introduction (NPI), and Quality.
• Where appropriate, act as project lead to set direction on core technical strategies for development programs. Coordinate project action items, including managing concurrent development threads. Delegate and manage tasks among internal team members to drive execution of project deliverables and minimize risk.
• Participate in brainstorm sessions and design reviews.
• Foster client relationships and serve as an accessible management representative for clients.
• Identify, intervene, and contribute to resolution of cross-functional and key customer program issues as they arise.
• Manage headcount of AGILE department across all disciplines, hiring and training additional employees as needed.
• Foster career development of direct reports, mentoring and coaching as appropriate.
• Ensure that direct reports are efficiently utilized and meeting billable targets.
• Manage resource allocation across projects. Optimize project team structures to ensure alignment of tasks with experience levels and promote technical development of engineers.
• Interface with prospective clients, provide overview of Resonetics capabilities as needed, and evaluate new opportunities.
• Prepare proposals for new development programs, including generation of detailed project timelines and budgets.
• Ensure adherence to Design Controls and broader Resonetics Quality procedures.
• Represent AGILE in discussions with other departments on-site to effectively address issues. Foster relationships with Lightspeed leadership, promoting open and streamlined communication and collaboration between AGILE and Lightspeed.
• Effectively escalate to senior leadership on complex matters requiring additional support and/or coordination between Resonetics sites.
• Participate in and drive department-level initiatives.
• Maintain a professional, credible image with consultants, suppliers, and co-workers.

Leadership

Demonstrate the ability to get things done individually and through others by delegating, influencing, and monitoring in order to bring work to completion. Inspire confidence, respect, and enthusiasm.

Customer Focus

Provide professional, reliable and prompt service to internal and external customers. Work in partnership with others to meet and exceed customer expectations. Interpret customers’ needs and take appropriate action. Follow through on customers’ inquiries in a professional and timely manner. Identify and communicate the most prudent path forward for the customer given the business goals of the customer.

Management of Resources

Be well organized and use time efficiently. Prioritize tasks effectively. Demonstrate initiative and innovation in the use of available resources.

Communication Skills
Assure that all verbal and written communications are concise, technically accurate, timely, and professional. Demonstrate strong verbal presentation and negotiation skills. Make presentations in a positive and professional manner. Express ideas, recommendations, and solutions clearly, logically, and concisely in both written and verbal communications. Demonstrate tact and diplomacy in communications. Demonstrate active listening skills and ability to resolve discrepancies with customers.

Team Building
Resolve conflict with others in an effective, positive, and mature manner while maintaining a constructive tone. Work well with others to meet goals.

Adaptability
Remain flexible and resilient. Respond positively to changing priorities. Accept new techniques and procedures quickly and employ them into daily job functions. Effectively handle special assignments outside of daily functions.

Business & Systems Knowledge
Demonstrate knowledge of raw materials, production processes, quality control and appropriate use of equipment. Utilize systems to complete assigned tasks. Identify opportunities to change processes or use technology to improve efficiency.

PREFERRED EDUCATION

BS Mechanical Engineering (or related discipline) preferred

PREFERRED EXPERIENCE

• Comprehensive knowledge of and intimate familiarity with the requirements of current versions of ISO 13485, ISO 14971 and FDA QSR
• Experience managing product development functions within a device or drug manufacturing environment
• Depth of knowledge in one or more clinical areas.

The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $111,000-$144,000.

Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.

Resonetics will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.