R&D Project Manager

Job DescriptionJob Description

Job Description: R&D Project Manager

Position: R&D Project Manager

Location: Charlotte, NC

Department: Development

Reports to: Director of Development

Company Overview:

At Aptyx, a new name backed by 70 years of expertise, we bring together the aptitude and excellence of more than a dozen companies with decades of experience helping customers in the life sciences and other demanding industries solve complex manufacturing problems with confidence so they can create more good things in the world. We are committed to delivering high-quality products and services to our customers worldwide. We are seeking a talented and experienced R&D Project Manager to join our dynamic team and contribute to our mission of excellence and innovation.

Job Summary:

The R&D Project Manager position performs the function of design engineer and group manager for product development work on medical devices in the Development department in support of the Development department's objectives to provide goods and services that meet customers' requirements for quality, quantity, and timeliness. The primary goal of the R&D Project Manager is to lead and coordinate project engineers, technicians, and assemblers to conduct development projects on time and on budget that meet the customer's objectives, bringing the projects to successful conclusions that meet all the clients' objectives. The R&D Project Manager will coordinate and delegate activities within the Aptyx Charlotte team, provide guidance to projects, and guide engineers to work towards successful project deliverables and meet the expectations of clients. In some cases, the engineering manager may also serve as the project manager.

Key Responsibilities:

• Customer Satisfaction: Prepare and support product development teams to ensure customer satisfaction with the outcome and deliverables of assigned projects. Support communication with the customer to resolve any issues and report project status. Escalate issues as needed for leadership support.
• Resource Management: Assign team members to projects based on allocated budget and project requirements. Balance workloads within the team and coordinate activities to achieve project goals. Work cross-functionally with other departments to ensure adequate resources are available.
• Training and Development: Mentor and guide staff on individual projects and career development through regular meetings and performance reviews. Train staff to collaborate with outside vendors to source materials, components, and processing. Manage the Team's hands-on product and process development of catheter, implant, and other disposable products.
• Financial Management: Support achievement of department financial objectives by managing costs and revenues to achieve profitability goals. Review and approve project invoices.
• Technical Support: Work with technical lead to provide technical support and troubleshooting for product development and project management. Supervise the preparation of documentation to support the quality system for design functions (project plans, concept documents, FMEA, design input, test results, drawings, etc.).

• Quality Assurance: Supervise development teams to ensure design and development practices are compliant with Aptyx QMS & applicable regulatory requirements.

• Sales Support: Participate in the project quotation process by generating and/or reviewing project budgets and timelines.

• Data Analysis: Utilize data analytics to support efforts to achieve department KPIs and company objectives. Prepare regular reports and presentations for senior management.
• Continuous Improvement: Recommend and support improvements to SOPs/QMS, business practices, technologies, and other opportunities that improve the quality and consistency of services/products provided to customers while achieving business objectives.
• Additional Responsibilities: This position may also include other duties as assigned to support the overall objectives of the Development department and the company.

Qualifications:

• Education: BS or MS in Engineering is required (Biomedical or Mechanical is ).
• Experience: Minimum of 8 years of experience in medical device development, 10+ years . Previous supervisory and/or management experience in the medical device field . US and International Regulatory requirements, quality management systems requirements, and varied medical device applications experience are highly for understanding project requirements.
• Technical Skills: Technical skills must include disposable device design and development background, materials knowledge, and prototyping. Experience with project and/or program management of medical devices.

• Problem-Solving: Excellent analytical and problem-solving skills, with the ability to identify root causes and implement effective solutions.
• Communication: Strong communication and interpersonal skills, with the ability to work effectively in a multicultural and cross-functional team environment.
• Travel: May require occasional domestic and international travel.

Benefits:

• Competitive salary and performance-based bonuses
• Comprehensive health, dental, and vision insurance
• Retirement savings plan with company match
• Paid time off and holidays
• Professional development and training opportunities
• Relocation assistance (if applicable)