Contraline, Inc. is a medical device company that is developing a novel long-lasting, non-hormonal, reversible male contraceptive.
Contraline is seeking a Director of Engineering to lead, create, and drive medical device development, primary and secondary packaging, and translating device designs into commercial manufacturing. This position involves hands-on medical device development, including the use of human factors engineering. The Director of Engineering will also be responsible for managing the overall device development programs including interaction with internal and external partners to develop, manufacture and assemble Contraline’s medical devices. The Director of Engineering will also work alongside Contraline’s R&D, clinical, and regulatory team to ensure that the novel devices are safe, effective, and useable. This role will initially report directly to the CEO.
- Lead product life-cycle product management of novel injectable contraceptive products, including development, manufacturing, and commercialization.
- Provide expertise in CAD software (e.g. solidworks) and prototyping
- Lead human factors engineering program including conducting usability studies and human factors validation testing for novel medical devices
- Lead the medical device development in accordance with 21 CFR 820.30 Design Controls (where applicable);
- Lead Contraline’s device risk management program including conducting risk assessments for device design, manufacturing, sterilization and usability.
- Oversee component suppliers, CMOs, and assembly installation, commissioning, and qualification activities.
- Ensure all verification and validation activities are conducted in accordance with Contraline’s quality management system and industry best practice
- Contribute to intellectual property creation and management
- Prepare and present progress and significant events for executive, cross-functional management review.
Applicants must meet the following criteria:
- MS degree in Engineering or related technical field preferred
- 5+ years of experience in the medical device industry with proven experience in developing and commercializing products with injection components; broad experience in developing products using design controls and human factors engineering
- Experience leading technical and cross-functional teams
- In-depth understanding of medical device product development life-cycle
- Deep knowledge and experience working with cGMP principles, concepts, practices and industry standards (e.g. ISO, AAMI, ANSI) as well as relevant related regulatory requirements for commercialization of medical devices
- Excellent communication, organization, and project management skills
- Creative, flexible, and independent thinking
- Works well in small, cross-functional teams