Principal Process Engineer / Director of Process Engineering

Company Description

Detect’s mission is to make accurate diagnostics accessible. We build breakthrough technology at the intersection of software, hardware, chemistry, and biology to make diagnostics available at the point of need. Our ultimate goal is to lower healthcare costs, improve patient outcomes, and improve doctor experience by enabling earlier diagnosis and access to treatment.

Job Description

Detect is seeking an onsite Principal Process Engineer / Director of Process Engineering to develop and implement Detect’s in-house manufacturing strategy. This individual is directly responsible for establishing, optimizing, and maintaining Detect’s production and test processes for high volume consumables and prototype system production at our Connecticut headquarters.

The ideal profile of this position calls for a flexible and well-rounded individual – someone who is self-motivated, detailed-oriented, and collaborative, with a breadth of technical and manufacturing understanding and strong communication skills. Successful performance in this role will require a blend of both strategic planning and substantial hands-on activities. Experience in developing production processes in an ISO-13485 / GMP environment is a plus, especially in the assembly of plastic diagnostic consumables.

As part of our team, your core responsibilities will be to:

• Establish Detect’s in-house production strategy, including capital planning, related compliance and documentation approach, and project planning.
• Develop, implement, and monitor day-to-day manufacturing processes in Detect’s Connecticut headquarters to drive yield, efficiency, and consistency.
• Determine production equipment needs. Lead and perform equipment and process validation activities (IQ/OQ/PQ).
• Design, produce, and qualify manufacturing fixtures, plastic laser welding routines, and production test platforms.
• Support cross-functional manufacturing efforts with R&D, engineering, and the rest of the operations organization.
• Organize and prioritize work with minimal guidance and manage priorities, projects and special requests in a timely and effective manner.
• Lead pFMEA activities to ensure process and manufacturing issues are identified and risks appropriately mitigated.
• Build and maintain relationships with all functions, external partners, and vendors to make decisions regarding manufacturing processes.
• Establish, monitor, and analyze key process metrics for day-to-day performance and to identify and evaluate opportunities for improvement.

Qualifications

Baseline skills/experiences/attributes:

• Bachelor’s or advanced degree in an engineering field, plus 10 years of relevant experience in medical device engineering and manufacturing, preferably in diagnostic devices and consumables. Experience in other industries in other highly regulated industries will also be considered.
• A leader that has a passion for all aspects of building robust production processes.
• Consistent track record of delivering complex projects from NPI to mass production.
• Ability to develop both high level production strategy and to execute the details of the high level plan.
• Experience with plastic laser welding, CAD (Solidworks or Fusion), machining, and injection molding are all highly desirable.
• Excellent problem-solver, has a strong quality & customer-focused mindset, and has the personal drive for success with professional skills.
• Comprehensive understanding of high-volume manufacturing processes and failure analysis.
• Extensive Knowledge in data analysis and analytics, and solid understanding of measurement control metrics including GR&R, Cp/Cpk and correlation analysis.
• Strong internal stakeholder management, data/information management, process design.
• Ability to manage numerous projects at once in a fast-paced environment.
• Experience leading and participating on cross-functional and/or global teams; easily connecting and building bridges with counterparts within different parts of the organization.
• Exceptional verbal and written communication skills.
• Proven ability to make complex and time-sensitive decisions in the best interests of the organization.
• Self-motivated team member who can drive resolution to issues with strong problem-solving skills.

 You Deeply Identify with Core Detect Values:

• Put people first. Our colleagues and our customers come first. We respect each other and celebrate our diversity. We take joy in each other’s success, and succeed or fail as a team.
• Eye of the owner. We have an ownership mindset and take responsibility for all of our decisions. No problem is someone else's problem. We are frugal and use company resources as if they were our own.
• No genius without grit. As innovators, we fail often but fast. We are tenacious. We push through adversity and keep getting up. We are problem solvers and always find a way.
• Err on the side of doing. We are scrappy and biased toward action — everyone is an individual contributor. We allow intuition to guide us when we have imperfect information.
• Move fast by working smart. We are inventors. We focus, plan, pursue, and adjust to make big things happen in a fraction of the time others can. We disagree and commit.
• Always be frank. We celebrate openness and diversity of opinion. We are transparent and candid but compassionate in our feedback, and are always honest to ourselves and our customers.

Additional Information

We offer great perks: 

• Fully covered medical insurance plan, and dental & vision coverage - as a health-tech company, we place great worth on our teams’ well-being.
• Competitive salaried compensation - we value our employees and show it.
• Equity - we want every employee to be a stakeholder.
• Pre-tax commuter benefits - we make your commute more reasonable.
• 401k plan - we facilitate your retirement goals.
• The opportunity to build a revolutionary healthcare product and impact millions of lives!

For this role, we provide visa assistance for qualified candidates. 

Detect does not accept agency resumes.

Detect is an equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.