Senior Manufacturing Engineer

THE COMPANY

Reprieve Cardiovascular ( / currently based in Milford, MA) is a pioneering medical device company focused on improving outcomes for patients suffering from acute decompensated heart failure (ADHF). The company’s Guided Diuretic Therapy is designed to provide clinicians with the ability to precisely tailor a therapy to an individual patient and maximize fluid removal, leading to improved cardiac and renal function and complete decongestion of ADHF patients. 

THE ROLE

The Senior Manufacturing Engineer will report to the Director of Operations and will be responsible for designing, developing, and optimizing manufacturing processes for the production of Reprieve’s medical devices, with special focus on custom disposable infusion sets and accessories . This role is essential in driving the company’s growth by ensuring that production processes are efficient, scalable, and aligned with regulatory requirements. You will work closely with cross-functional teams including R&D, Quality, and Regulatory to ensure that our products meet the highest standards of safety, consistency, performance, and regulatory compliance. The successful candidate will be energized by the idea of changing the paradigm of heart failure treatment for patients, working in a fast-paced, early-stage environment, and must be strategic and tactical in their thinking with a hands-on, roll-up their sleeves mindset. Reprieve believes strongly in promoting from within the company wherever possible, and so career growth opportunities will emerge for interested employees as the company expands.

KEY RESPONSIBILITIES

• Process Development: Design, develop, and implement manufacturing processes for both disposable infusion sets and electro-mechanical fluid management instrument to ensure efficiency, scalability, and cost-effectiveness.
• Process Improvement: Continuously monitor and improve existing manufacturing processes to increase efficiency, reduce waste, and ensure product quality.
• Quality Assurance: Collaborate with quality to ensure all manufacturing processes comply with regulatory standards (FDA, ISO 13485, etc.) and maintain product quality and facilitate regulatory audits.
• New Product Introduction: Work closely with R&D during the design phase to ensure manufacturability and participate in the transition from prototype to full-scale production, ensuring timelines, cost, and quality objectives are met.
• Equipment Design & Validation: Design, specify, procure, and validate manufacturing equipment, ensuring it meets production requirements and complies with industry regulations.
• Documentation & Compliance: Create and maintain detailed manufacturing documentation, including process instructions, validations, and change controls, in accordance with Good Manufacturing Practices (GMP).
• Root Cause Analysis: Work with cross functional teams to investigate production issues, perform root cause analysis, and implement corrective actions to prevent recurrence.
• Cost Management: Assist in the identification and implementation of cost-saving initiatives related to materials, labor, and production processes.
• Training & Support: Provide technical support and training to manufacturing staff to ensure the correct operation of equipment and adherence to processes.

REQUIRED QUALIFICATIONS

• Education: Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field.
• Experience: A minimum of 8-10 years of experience in medical device manufacturing engineering. Experience with disposable medical device manufacturing essential, preferably in disposable tubing sets and accessories .
• Regulatory Knowledge: Strong understanding of FDA regulations, ISO 13485, experience with Design History Files (DHF) or EU MDR Technical Files.
• Technical Skills: Proficiency in CAD software (SolidWorks preferred); experience with Six Sigma tools, statistical analysis software (Minitab, JMP), and ERP systems. Experience with Six Sigma tools a plus.
• Problem-Solving: Demonstrated ability to identify, analyze, and implement solutions for design for manufacture, production, and process issues.
• Communication: Excellent verbal and written communication skills; able to effectively collaborate with cross-functional teams.
• Detail-Oriented: High attention to detail with the ability to manage multiple projects and deadlines.
• Leadership Skills: Ability to lead cross-functional teams and manage complex projects.

PREFFERED QUALIFICATIONS

• Experience with automation systems, robotic integration, industry 4.0 technologies, and process control systems.
• Knowledge of Design for Manufacturing (DFM) and Design for Assembly (DFA) principles.