Sr. Process Engineer - Pattern Bioscience

At Pattern Bioscience, we’re tackling antibiotic resistance, one of the biggest public health challenges of our time.  We use machine learning and microfluidics to quickly recognize the bacteria causing an infection and to predict which drugs will cure the infection.

We are looking for a results-driven Senior Process Engineer to lead complex projects focused on improving safety, quality, and efficiency of our consumable manufacturing processes. This role enables our manufacturing operations to scale for clinical trials and commercialization through process optimization, equipment validation, and root cause analysis. As a core member of our Consumable & Automation Engineering team, you will enhance process capability and capacity, reduce downtime and scrap, support new product transitions, and optimize equipment performance, including controls and HMI systems. This role is for you if you are an optimizer at heart and you have a focus on details and using data to inform your work.

How You Will Contribute

• Evaluate processes, identifying and documenting deficiencies and recommending improvements to processes or equipment.
• Enhance process capability and throughput by optimizing equipment utilization, minimizing downtime, reducing variation, and driving waste reduction and yield improvements.
• Diagnose the root cause of equipment failures.
• Lead the design, development, and implementation of new production lines and facilities requirements.
• Develop, implement, and integrate equipment specifications and validation documents—including FAT, SAT, IQ, OQ, and PQ—into the QMS for both custom and off-the-shelf manufacturing equipment.
• Ensure compliance with regulatory standards and organizational quality SOPs
• Investigate, develop, analyze, and maintain ongoing process performance metrics to eliminate systemic deviations and to optimize equipment or processes.
• Support the transition of new products from development to production, ensuring Design for Manufacturing (DFM), clear documentation and well-defined processes.
• Review, test, and modify equipment controls and HMI systems to enhance usability and optimize equipment performance and operation.
• Support Production team with troubleshooting and resolution of manufacturing challenges.

We'd Love to Hear from You If You

• Can demonstrate strong technical independence, exceptional project management skills, and leadership in the development and implementation of a production line.
• Are proficient in analytical and statistical methods and process control (SPC, DOE, FMEA).
• Lead cross-functional projects from concept to implementation.
• Have commissioned, qualified, and validated custom and off the shelf production equipment.
• Are an independent and creative problem solver who appreciates a hands-on environment.
• Run effective DOEs that result in improved product quality and process efficiency.
• Comfortably use CAD and layout tools to review and update equipment documentation and production layouts
• Understand and have practical experience with a QMS environment, including design controls, risk assessments, and change controls.

Desired Education and Experience

• B.S. in engineering with 7+ years of process engineering experience
• Proven track record of implementing continuous improvement initiatives utilizing methods from Six Sigma, Lean Manufacturing, etc.
• Hands-on experience with automation equipment, including testing, troubleshooting, optimization, validation, and integration
• Proven experience with validation cycle (FAT, SAT, IQ, OQ, and PQ)
• Experience in new product introduction (NPI) and technology transfer to manufacturing

Skills or Attributes Considered a Plus:

• Experience manufacturing medical device consumables
• Experience in an FDA regulated environment
• Knowledge of Good Manufacturing Practice (GMP), ISO 13485, ANSI, and/or NEC safety standards
• Proficient in SolidWorks

Additional Details

• This role may require flexible hours to support production schedules and urgent process issues.
• Onsite; 5 Days/Week

Benefits

• Medical, Dental, Vision, Short-Term Disability, and Life Insurance
• 401k Match
• Paid Time Off
• The opportunity to make a global impact and pioneer solutions

To fulfill our mission and build world-changing technology, we’ve put together a diverse, multi-disciplinary top-notch team, a culture of innovation, learning, adaptability, and excellence and environment where people love coming to work.

We value diversity on our teams. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity or expression, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.