Manufacturing Engineer

May Health is a precommercial stage, venture backed, medical device company committed to transforming care for women with Polycystic Ovarian Syndrome (PCOS). PCOS is an endocrine disorder which affects >10% of women of childbearing age. PCOS is a leading cause of female factor infertility and 50% of these women will seek treatment. In addition to fertility struggles, women suffer for years from hormonal imbalance which causes irregular and painful periods, acne, thinning scalp hair, and excess hair growth on the face and body.

The consequences of PCOS can be devastating as ½ of PCOS sufferers will develop type 2 diabetes by the time they are 40 and are at increased risk of heart disease and stroke.

The team at May Health currently is focused on driving enrollment in their US IDE study, REBALANCE. The Company anticipates enrolling approximately 195 patients at up to 35 U.S. Sites. The company also has a CE Mark application underway.

Position Summary

Key contributor within the R&D / Operations team involved in the planning and execution of manufacturing engineering & production activities, developing technologies, and supporting R&D, clinical & commercial operations.

Essential Job Functions

Core Responsibilities

• Contribution to process validation planning, documentation and execution.
• Design and development of manufacturing processes and fixtures.
• Initiation and/or maintenance of manufacturing and DMR documents.
• Equipment Cal/PM and installation/validation support.
• Line support and participation in verification & validation, clinical and commercial product manufacturing builds.
• Assistance with inventory control and supply chain activities.
• Involvement with Quality System activities including inspections, testing, and test method validation.
• Collaboration and management of contract manufacturer.
• Interaction and guidance for key vendors.
• Support of manufacturing transfer into the Company.
• Collaboration with other departments to obtain input and share objectives.
• Maintenance of product information and standard operating procedures within the Company’s documentation system.

Qualifications, Experience & Education

• Bachelor’s degree in engineering or related field.
• 5-10 years’ experience in engineering/operations roles at medical device companies.
• Experience with manufacturing process development and process validation.
• Experience with technical writing, including test protocols and reports, manufacturing process instructions, etc.
• Demonstrated ability to complete tasks and support projects per department and company-wide timelines.
• Knowledge of medical device regulatory requirements and Quality Management Systems.
• Knowledge of statistics and data analysis.
• Ability to communicate effectively to all levels of the organization and customers (strong written and verbal skills).
• Project management and problem-solving abilities.
• Excellent interpersonal skills.
• Integrity and self-motivation.
• Experience working in various size organizations, especially in small company, start-up environments.
• Experience working in both small teams and individually.
• Experience working with and managing outside suppliers/vendors and contract companies.

Computer and Equipment Skills

• Strong proficiency with Microsoft Office Suite (Word, Excel, PowerPoint) for reporting, documentation and presentations.
• Competence in Solid Works or similar 3D modeling programs.
• Experience with equipment and hand tools commonly used in medical device design and manufacturing, including pouch sealers, tensile testers, UV adhesive systems, microscopes, forces gauges, calipers, ect.

Physical Demands

• Requires the ability to lift up to 40 pounds frequently, stand or sit for extended periods, bend, walk, climb stairs. Also requires daily use computer to perform essential functions of the role.

Work Environment

• Requires the ability to work near mechanical parts that may emit occasional noise or vibration. Occasional exposure to wet or humid conditions (non-weather related).

We are an Equal Opportunity Employer and do not discriminate on the basis of race, color, religion, sex, national origin, age, disability, veteran status, or any other protected characteristic. All qualified applicants are encouraged to apply.