Product Development Manager

Description

The Lightspeed Department Manager leads the Lightspeed team.

This role involves managing engineers and technicians, executing development, and prototyping projects, and overseeing sales, marketing, and customer communication efforts.

The manager will also be responsible for compliance with industry standards, transitioning projects from development to production.

Responsibilities

• Team Management: Lead the Lightspeed team, including engineers and technicians, to ensure efficient daily operations and project execution.
• Project Management: Manage customer order projects, including providing quotes, adhering to schedules, and ensuring the successful development and production of prototypes.
• Business Development Develop and maintain customer relationships to drive business growth.
• Production Processes: Develop and improve production processes based on customer requirements and ensure a smooth transition from development to production using prep methodology.
• Technical Solutions: Provide technical solutions while working closely with engineers and technicians to meet project deadlines.
• Cross-Departmental Collaboration: Collaborate with other departments, including Production, Sales, Operations, and Quality Assurance, to ensure seamless project execution and customer satisfaction.
• Regulatory Compliance: Ensure compliance with 21 CFR and ISO13485 standards in all department activities.
• Strategic Representation: Act on behalf of the site manager in all non-financial matters, guiding the strategic direction of the Lightspeed department.

Authorities:

• Pricing and NDA Approval: Issue price quotes and approve Non-Disclosure Agreements (NDAs).
• Team Leadership: Direct the Lightspeed team, setting goals and monitoring performance.
• Resource Management: Responsible for the equipment and resources within the Lightspeed department.

Required Qualifications

-Education

-Experience

-Skills

• Education: B.Sc. in Mechanical, Biomedical, or related Engineering fields.
• Experience: At least 5 years of experience in the medical devices industry, including business development, customer communication, and team management.
• Technical Skills: Proficiency in MS Office Suite and SolidWorks, understanding of development processes and NPI, familiarity with electrochemical processes and surface treatments.
• Other Skills: Excellent analytical skills, problem-solving abilities, and experience working with customers.
• Personal Traits: Strong leadership, communication, and teamwork skills. Detail-oriented and capable of working in a highly regulated environment.

Preferred Qualifications

• Familiarity with design for manufacturability.

Physical Demands

• Comfortable working in a highly regulated environment.