Director, Engineering

Position Summary

We are seeking an innovative and highly motivated Director of Engineering who will contribute significantly to the growth of Cellares and our mission to accelerate access to life-saving cell therapies. This person will report to the VP of Technology.

As the Director of Engineering, you will take responsibility for growing and directing a team tasked with a wide range of responsibilities pertaining to high value internal projects: exploring new architectures, design proof-of- concept prototypes and forward looking enhancements.  Translate high level requirements to hardware and subsystem level specifications ensuring  traceability to downstream deliverables. Contribute to architecture development and documentation, risk management and safety analysis.

This position has both a strategic and a technical role inside the company: The strategic aspect includes setting goals for the team, hiring and mentoring engineers and prioritizing tasks and projects. The technical aspects are about getting actively involved in developing new and exciting products by exploring conceptual designs, investigating novel approaches to enhance Cellares’ technological profile and engineering from feasibility to launch.  In this role, you will be required to provide in-depth analysis and help guide important decisions during design reviews and architecture discussions. 

This is a multidisciplinary role & this individual will interface across many parts of the company (with scientists, researchers, and engineers) to develop the best solutions possible.

This is a leadership role that includes team and time management. Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

• Drive the design and development of the company's Hardware products to unlock global scale
• Lead the Hardware product development through various lifecycle stages from conceptualizing to defining HW technical architecture to launching for production
• Lead and manage a team of mechanical, controls, and electrical engineers
• Provide technical guidance to the team members and lead the hands-on work
• Accountable for Hardware performance, cost target, quality, and timeline while working closely with HW platform/technologies team and HW test team
• Drive shared practices and parts for hardware scalability
• Collaborate with Product Management, Supply Chain, Software, and other teams to transform tested conceptual solutions into robust, scalable products
• Collaborate with cross-functional engineering teams and external vendors to develop a fully functional product that solves customer problems
• Prototype and test the solutions to quantify system performance, quality, and maturity of the solutions
• Write and maintain design documentation that communicates device design, capabilities, and procedures
• Drive the design and release of components and systems using SolidWorks
• Support the creation of production and support documentation including bills of material (BOMs), assembly drawings, electrical drawings, schematics, and maintenance instructions
• Lead teams through complex root-cause analyses that involve various areas of physics and engineering, using a structured approach for problem solving
• Participate in the process to ensure completeness of the design history file
• Support regulatory submissions including creation, review, and management of technical documents

• Bachelor’s degree or higher in ME, EE, or other related engineering disciplines
• 10 years of related work experience, including having advanced designs from initial concept through scale production
• 5 years of experience leading and managing HW teams to build multi-disciplinary systems
• Proven experience in developing and launching medical/IVD products to the regulated market
• Ability to manage multiple engineering efforts concurrently
• Experience working with customers (internal or external) and global contract manufacturers and vendors
• Hands-on mechanical design experience using 3D CAD, preferably SolidWorks, including 2D drawings and simulations
• Experience with designing complex robotics systems
• Familiar with ASME and ISO drafting standards
• Experience with DFM/A and statistical tolerance analysis
• Experience in failure avoidance methods including DFMEA and fault tree analysis
• Solid knowledge of regulatory standards such as ISO13485, ISO 14971, FDA QSR 21 CFR 820, 21 CFR Part 11 and standards applicable to medical devices  
• Demonstrated experience in development, characterization and testing of complex instrumentation systems
• They must also combine impressive technical leadership, excellence in people management and commitment to the highest standards of program execution, to operate successfully within a highly collaborative and interdisciplinary Product Development team
• Substantial experience scaling and building highly technical hardware / product development teams including the management of Contract Engineering organizations
• Ability to lead integration of mechanical, electrical, optical, and fluidics projects that result in sophisticated yet elegant and robust products
• Demonstrated ability to attract, develop and retain top talent while providing mentorship and career advancing opportunities
• Demonstrated listening and synthesizing skills

Annual Salary Range: $170,000-$220,000

Cellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent.

This is Cellares

Cellares is creating the future of cell therapy manufacturing. The company is developing an innovative cell therapy manufacturing solution that is robust, cost-effective and scalable so that cell therapies are more affordable and widely available to patients in need. Our multidisciplinary team comes together from diverse backgrounds with a shared passion for accelerating access to life-saving cell therapies. We value integrity, curiosity, the courage to grow and embrace change. At Cellares, you will collaborate with a world class team of engineers, scientists, and business leaders who are as excited about improving the world as you are.

Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.

Salary : $170,000 - $220,000