Sr. Research & Development Engineer

About Alydia Health

Alydia Health is a venture backed, clinical stage medical device company developing technology to treat postpartum bleeding, change obstetric care and improve the mortality and morbidity associated with postpartum bleeding. As an early-stage medical device company we are dedicated to making childbirth safer for all mothers. Alydia has developed the Jada System, an investigational device designed to rapidly stop abnormal bleeding following childbirth which will serve as the basis for FDA approval in 2020.

We are a team of dedicated, mission-driven people, and as a small company, every team member at Alydia makes a big contribution towards our mission. We seek candidates who are passionate about improving healthcare and women’s healthcare and is motivated to do the hard and exciting work required to bring a ground-breaking technology to market.

Primary Function of Position:

Reporting to the VP of R&D, the Senior R&D Engineer will use their in-depth knowledge of medical device development to work with other engineers and clinicians to define, develop, prototype and validate the clinical function of current and new products within Alydia Health. This person will also be the primary interface with tooling and prototype partners and a contract manufacturer.

Major Responsibilities:

The position has responsibility and authority for:
• Conducting research to solve clinical problems using a variety of means to collate the necessary information, including interviews and questionnaires.
• Design, model, and test prototypes for product development and improvements.
• Conceive, design and build appropriate test fixtures to achieve reliable test data to compare product design options.
• Create concepts, performance, and production criteria.
• Effectively interpret test results and characteristics to improve product performance.
• Proficient in CAD tools to produce prototype and production level drawings.
• Identify and select materials needed for production.
• Produce final hand and computer aided design drawings and specifications.
• Work with manufacturing companies.
• Travel to production facilities to evaluate processes.
• Work with manufacturers to achieve production-level designs.
• Author product specifications, requirements, and Instructions for Use.
• Prepare, author, and execute Verification & Validation protocols and reports to confirm product performance.
• Assess the developing market for products modifications suggested by health professionals or others.
• Improve usability of products.
• Discuss and solve problems with manufacturing, quality, and marketing departments.
• Assist in clinical trials of Alydia Health products.
• Keep up to date with new developments and research in the field, nationally and internationally.

Maintain good laboratory notebook practices:
• Assist with the completion of regulatory submissions

Additional Responsibilities:

• Ability to travel up to 25% internationally and domestically.
• Assist Quality Assurance and Document Control in order to meet Alydia Health’s document requirements and maintain QSR compliance.
• Assist with development of intellectual property portfolio.

Level of Supervision Required:

• Communication with VP and Alydia Health team with weekly meetings to establish nearand long-term goals and objectives.
• Largely self-directed with low level of direct supervision needed to achieve goals.

Position Requirements:

• Minimum 5 years of experience in the medical device industry.
• Proficiency in SolidWorks for solid models and dimensioned drawings.
• Experience working with physicians on clinical matters and product        design improvement ideas.
• Proficient in understanding and engaging in anatomic discussions.
• Excellent mechanical aptitude, technical understanding and intuition for design and development.

Preferred Experience:
• 5+ years of progressive experience in a medical device R&D role, as well as working in a crossfunctional environment.

Preferred Education:
• B.S. in Mechanical Engineering, Biomedical Engineering or similar preferred.

Preferred Skills:
• Excellent interpersonal, organizational, problem-solving, and written/verbal communication skills, confidence, and ability to work effectively with a wide variety of medical, research and administrative personnel within the company.
• Excellent teamwork skills with proven ability to cultivate collaboration within group and across multiple disciplines to ensure project success.
• Strong time-management and individual travel management skills.
• Strong organizational skill with attention to details.
• Professional interactions in office and with customers and vendors.
• Good documentation skills.
• Strong computer skills and electronic data capture experience.
• Self-confident and able to react quickly under pressure.
• Ability to multi-task and prioritize with flexibility required in a start-up environment.
• Able to balance working independently and within a team on a variety of projects.
• Proficient in MSWord/Excel/Project/PowerPoint.

Physical Demands:
The physical demands described here are representative of those that must be met by the employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essentials functions of the role.

Light work positions involving sitting, standing, and walking. Position requires ability to frequently exert 10 pounds of force to move objects and occasionally exert up to 20 pounds of force to move objects.

Balance    Crouching     Kneeling     Lifting     Reaching    Talking    Standing
Feeling     Hearing         Grasping     Fine motor skills        Repetitive motion

This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position.

Employees will be required to follow any other job-related instructions and perform any other job-related duties required by the supervisor.

Alydia Health is an equal opportunity employer and does not discriminate in employment or hiring practices on the basis of race, sex, age, handicap, religion, national origin or any other basis prohibited by law.

All applicants should be legally entitled to work for any employer in the U.S.