Who Are We?
Prolaio believes that continuous learning and collaboration can make a significant difference in how heart care is administered. We are creating smarter ways to address heart disease and heart risks by uniting patients, care teams, and researchers on a secure, technology-enabled platform that drives clinical innovation and offers a path towards better patient outcomes.
This is precision cardiology, and we know it’s within reach.
What Will You Do?
The Overview
The Senior Manager, Manufacturing is accountable for manufacturing operations, production planning, and operational execution in a regulated medical device environment. This role leads manufacturing readiness, workforce management, and cross-functional execution while partnering with Quality, Systems, Supply Chain, and Engineering to ensure compliant, efficient, and scalable operations. The role is responsible for maintaining a safe, controlled, and continuously improving manufacturing environment.
The Specifics
- Own daily manufacturing operations including provisioning, kitting, returns management, and work order execution
- Lead production daily planning for WIP and MTS manufacturing and operational resource scheduling
- Manage and develop manufacturing personnel including training execution, growth path development, and performance management
- Maintain operational floor control and compliance, ensuring cleanliness, organization, and readiness to support manufacturing activities in a continuous state of control
- Own inventory control activities to ensure physical accuracy, traceability, and alignment with system records, maintaining inventory in a validated state of control
- Serve as manufacturing owner for change control implementation and operational execution
- Partner with Systems on ERP processes, item master data, BOMs, and manufacturing configuration
- Collaborate with Quality on SOPs, MWIs, and DMR related activities
- Support RCCP, S&OP, inventory planning, purchasing inputs, and depot planning with Supply Chain
- Ensure compliance with FDA, ISO 13485, and internal QMS requirements
Why Prolaio?
- Impactful Work: You will join in the fight against heart failure (HF) and hypertrophic cardiomyopathy (HCM) with the goal of extending and saving the lives of our patients while also being at the forefront of changing the healthcare industry through technology.
- Innovative Environment: You will be part of an organization doing something that’s never been done before.
- Professional Growth: You will join a growing team and have a substantial impact on our daily and future operations with the opportunity to continuously learn and grow.
- Collaborative Team: You will be part of a team of collaborative, curious, and committed individuals focused on the collective good, inclusiveness, scientific excellence, and advancing digital health for cardiology.
Who You Are?
- Bachelor’s degree in Engineering, Manufacturing, or related field
- 8 plus years of manufacturing operations experience in a regulated environment
- Prior people management experience
- Strong working knowledge of ERP systems, change control, and production planning
- Experience operating within FDA and ISO 13485–regulated environments, with a proven track record of audit readiness and compliance.
Why You’ll Love Working Here
- Meaningful Compensation: Competitive salary, performance bonus, and equity so you can share in what we build.
- Great Health Coverage: Medical, dental, and vision plans with multiple options and strong company contributions.
- Flexible Spending Perks: HSA, FSA, commuter benefits, and a $1,200 annual Lifestyle Spending Account to support wellness, commuting, family needs, and more.
- Time to Recharge: Generous paid time off, sick leave, and company holidays.
- Family-First Benefits: Paid parental leave, caregiver leave, and support for growing families.
- Security & Peace of Mind: Company-paid life insurance and short- and long-term disability coverage.
- Plan for the Future: 401(k) plan to help you build long-term financial security.
- Care When You Need It: Easy access to telehealth and optional supplemental coverage for life’s unexpected moments.
Starting Salary is at $161,000.00 (Exact Compensation may vary based on skills, experience, and location)
Prolaio is an Equal Opportunity Employer (EOE) that welcomes and encourages all applicants to apply regardless of age, race, color, religion, sex, sexual orientation, gender identity and/or expression, national origin, disability, veteran status, marital or parental status, ancestry, citizenship status, pregnancy or other reasons prohibited by law.
