Contraline, Inc. is a medical device company that is developing a novel long-lasting, non-hormonal, reversible male contraceptive.
Contraline is seeking a Principal Engineer to drive medical device development, primary and secondary packaging, and translating device design into commercial manufacturing. This position involves hands-on medical device development, including the use of human factors engineering. The Principal Engineer will also work closely with 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 Director of R&D.
- Execute on 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
- Support human factors engineering program, including conducting usability studies and human factors validation testing for novel medical devices
- Conduct medical device development in accordance with 21 CFR 820.30 Design Controls (where applicable);
- Support 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
- 3+ 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
- 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