Title: Engineering Manager
Summary: This position coordinate activities of the Engineering department utilizing all employees of the assigned Engineering groups for the development, manufacture, release and launch of products. The Engineering department is responsible to complete the design, analysis, prototyping, testing and validation of the product to ensure that all design control activities are completed in accordance with current GMP, FDA, ISO, MDD, EU and QMS regulations. This position will also be responsible for supervising all department resources and provide leadership within the company to ensure adherence to the company’s Vision, Mission and Strategic Plan by performing the following duties personally or through subordinate supervisors performing the following tasks.
Essential Duties and Responsibilities:
- Oversee the fulfillment of the strategic vision for the Engineering organization to ensure products are aligned with overall business and market strategy.
- Provide technical leadership in setting strategy with regard to technical and product structural issues, choice of methodology and standards.
- Manages department activities to design new products, modify existing designs, improve production techniques, and develop test procedures.
- Responsible for the design and development of medical devices from concept to finished product following all Design Control procedures.
- Responsible for overseeing the design, manufacture, validation and implementation of the tooling and fixtures needed for the inspection and assembly of the product.
- Advises Management of new developments which may affect profit, schedule, costs, customer relations, and/or inter-departmental relations.
- Resolves problems using solutions that involve new techniques, technologies, or concepts.
- Maintains a working knowledge of safety policies and regulations to ensure duties of self and others are performed in a safe manner.
- Maintain and follow proper compliance and quality systems requirements.
- Provides leadership to employees in all areas including: hiring, performance management, coaching, counseling and corrective actions.
- Responsible for all meetings, project plans and team members including working with all individuals from supporting departments such as Quality, Manufacturing, and Sales
- Oversee the gathering, tracking and analyzing of all product data, i.e. yield/outputs/efficiencies in conjunction with Quality
- Oversee the completion of root cause analysis for non-conforming product.
- Assist with manufacturing to resolve Production issues as required.
- Responsible for the review of designs to ensure manufacturability and verify costs to meet project requirements.
- Responsible for overseeing design reviews, FMEA’s and all applicable verification/validation testing for completion and release of the products to market.
Education and/or Experience
- Bachelor’s degree in Electrical or Biomedical or related discipline, but prefer a Master's degree. 10+ years’ technical development and/or technical managerial roles. 5+ years leading successful teams.
- Electrical Background in ultrasound circuitry and sensors (preferred)
- Experience developing and producing Doppler Ultrasound technology (Preferred)
- Working knowledge of electronics and probe technology
- RF experience is a plus
- Demonstrates successful management and team building experience in a rapid growth environment.
- Proven technical accomplishments in the development, delivery and deployment of successful products to market.
- Demonstrable business decision-making experience.
Interested applicants can also email resumes to [Click Here to Email Your Resumé]
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178