Sr. Process Engineer, Business Engineering

  • Full-time

Company Description

Finding a good job is very good.

Finding a good job in a dynamic, growing company is great.

Finding a great job in a world-changing organization is a once-in-a-lifetime opportunity.

Welcome to Proteus Digital Health, where we’re pioneering a new category of products, services and data systems based on ingestible computing. Our core technology – the digital health feedback system – provides an unprecedented view into an individual’s personal health choices and physiologic response. This care-altering feedback system enables patients to better manage their health, allows more effective collaboration with caregivers and clinicians, all while enabling new information-based business models.

What Amazon did with books, and Apple did with music, Proteus is poised to do with digital medicine. Come join our unique collection of innovative scientists, engineers, market makers, designers, doctors, developers, clinicians, and other digital health industry pioneers, and help us dramatically improve the lives of tens of millions across the globe.

Learn more about what we do (video): https://proteus.app.box.com/BuildersandInnovators

Job Title: Sr. Process Engineer, Business Engineering

Team: Business Engineering

Reports To: Head of Business Engineering

The energy and culture at Proteus is a contagious mix of passion, focus, relentless determination, and serious fun. Proteans are mission-minded and collaborate in a way that’s refreshingly encouraging. With all of this comes success and then growth, which is why you’re reading this now because we are seeking an experienced Process Engineer, Business Engineering.

In this role, you will work with the business engineering team to support Proteus’s digital medicine program and create novel efficient and effective operations to support commercial production. You will also apply technical knowledge to innovate, design, develop and implement both technical and business process solutions. Additional facets of the role include: coordinating and aligning production and development efforts with program goals, as well as working closely with program managers, software development, pharmaceutical development, customer partnering and internal/external manufacturing teams. But it doesn’t end there. Here’s a summary of this great opportunity:

Job Description

  • Lead internal and external teams to build and support business operations for digital drug products intended for clinical studies and commercial markets
  • Partner with customer partnering to realize scale-up goals through equipment and process introductions
  • Function as technical expert to formulate solutions to complex commercial operation challenges relate to digital medicines
  • Investigate and resolve commercial operation manufacturing and supplier quality concerns
  • Develop and execute novel test plans for solid dosage forms integrating ingestible sensors with pharmaceutical tablets or capsules to support extended commercial use
  • Lead equipment deployment, qualification and training at 3rd party operation sites, estimated travel 10-20% of time
  • Must be hands-on and capable of designing and implementing experiments
  • Support offsite manufacturing operations and scale up
  • Author and/or mentor team in generation of production work instructions for specific equipment and processes
  • Record and maintain documentation in support of Quality System

Qualifications

  • Bachelor’s degree in Engineering, or related field
  • 5 plus years of Process Engineering experience in supporting manufacturing and/or commercial operations in a regulated environment (medical device/pharma/pharmacy/combination products)
  • Understanding of GMP manufacturing to ensure rapid integration into production
  • Experience with capsule dose forms and capsule manufacturing
  • Understanding of equipment validation and transfer process from R&D to production
  • Familiarity with pharmacy operations and compounding process a plus
  • Superb verbal and written communication skills
  • Excellent organizational skills along with strong attention to detail
  • Ability to work both independently and collaboratively with small, cross-functional teams
  • Highly proficient with Microsoft Office Suite

Reasoning Ability

Ability to apply principles of logical thinking to a wide range of intellectual and practical problems.

Physical/Mental Demands

The physical and mental demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit; use hands and/or fingers to handle or feel; reach with hands and arms; talk and hear. The employee is occasionally required to stand and walk. The employee may occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus.

Additional Information

Ready for the ride of your life? We’re looking forward to receiving your resume!

We provide our employees with a great benefits package, which includes: medical/dental/vision insurance, 401K, paid time off (PTO)—including your birthday off, employee stock options, a bright & awesomely designed physical work space, a complimentary wearable device (i.e. Fitbit), fitness centers, and, of course free snacks & beverages.

About Us: Proteus has received FDA market clearance in the U.S. and a CE mark in Europe for its wearable and ingestible sensor devices. Headquartered in Redwood City, Calif., Proteus is privately held and funded by Carlyle, Essex Woodlands, Kaiser Permanente, Medtronic, Novartis, Otsuka, Oracle, ON Semiconductor, and other investors.