SetPoint Medical’s Engineering Manager will lead a team of exceptional manufacturing and sustaining engineers. The successful candidate will be responsible for managing the engineering support throughout SetPoint Medical’s supply chain, ensuring that all quality and regulatory standards are met while maintaining cost-effectiveness and efficiency. This position will report to the Vice President of Operations.
This position is in office, Monday - Friday, reporting to company headquarters in Valencia, CA.
- Manage a team of engineers responsible for the manufacture of medical device products.
- Implement design control processes and procedures to ensure compliance with regulatory requirements.
- Lead process qualification activities to ensure medical devices are manufactured constantly and meet required quality and regulatory standards.
- Ensure qualification activities are planned, executed, and documented appropriately.
- Collaborate with cross-functional teams, including Product Development, Quality, and Program Management to ensure that products meet customer requirements and business objectives.
- Lead and participate in design reviews, risk assessments, and other activities to ensure that products meet design and regulatory requirements.
- Develop and manage project plans, timelines, and budgets to ensure that projects are completed on time and within budget.
- Hire, train, and mentor staff to ensure that they have the necessary skills and expertise to perform their job duties effectively.
- Foster a culture of continuous improvement, optimization, innovation, and collaboration within the engineering team.
- Ensure that all engineering work is conducted in compliance with company policies, procedures, and regulatory requirements.
- Bachelor's degree in engineering (mechanical, electrical, or biomedical) or a related field. Master’s degree preferred.
- Minimum of 8 years of experience in medical device product development, with at least 3 years in a leadership or management role.
- In-depth knowledge of FDA regulations and ISO standards related to medical device design and development.
- Strong project management skills, with the ability to manage multiple projects simultaneously.
- Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
- Strong analytical skills, with the ability to use statistical analysis and other validation techniques to make informed decisions.
- Experience with design control processes and procedures.
- Proficiency in computer-aided design (CAD) software, such as SolidWorks or Pro/Engineer, preferred.
Skills and Abilities
- Attention to detail.
- Ability to organize, learn quickly, multi-task, adapt to change and perform in a fast paced, dynamic, and quality driven environment.
- Exceptional ability to work in a team, collaborate and build strong relationships.
- Knowledge of FDA regulations and ISO standards related to medical device design and development.
- Ability to manage complex projects and prioritize to meet department and corporate milestones.
- Strong leadership and mentoring skills, with the ability to motivate and develop staff.
- Strong problem-solving and decision-making skills.
- Company Headquarters in Valencia, CA.
- Relocation is not available.
SetPoint Medical is a clinical stage medical device company developing the first implantable bioelectronic device for the treatment of chronic inflammatory diseases.