Senior Manufacturing Process Engineer

2 weeks ago

Guilford, Connecticut, United States DeTect Full time

Company Overview

At Detect, our mission is to enhance accessibility to precise diagnostics. We innovate at the crossroads of software, hardware, chemistry, and biology to ensure diagnostics are available wherever needed. Our ultimate aim is to reduce healthcare expenses, enhance patient outcomes, and improve the experience for healthcare providers by facilitating earlier diagnosis and treatment access.

Position Overview

Detect is in search of an onsite Principal Process Engineer / Director of Process Engineering to spearhead the development and execution of our internal manufacturing strategy. This role is pivotal in establishing, refining, and sustaining Detect's production and testing processes for high-volume consumables and prototype systems at our headquarters.

The ideal candidate will be a versatile and well-rounded professional – self-driven, detail-oriented, and collaborative, possessing a comprehensive understanding of technical and manufacturing principles along with strong communication abilities. Success in this position will necessitate a combination of strategic foresight and significant hands-on involvement. Experience in creating production processes within an ISO-13485 / GMP framework is advantageous, particularly in the assembly of plastic diagnostic consumables.

Key Responsibilities

  • Formulate Detect's internal production strategy, encompassing capital planning, compliance, documentation, and project management.
  • Design, implement, and oversee daily manufacturing operations at Detect's headquarters to enhance yield, efficiency, and consistency.
  • Assess production equipment requirements. Lead and conduct equipment and process validation activities (IQ/OQ/PQ).
  • Engineer, produce, and validate manufacturing fixtures, plastic laser welding procedures, and production testing platforms.
  • Collaborate with cross-functional teams in manufacturing, R&D, engineering, and operations.
  • Organize and prioritize tasks with minimal oversight, managing priorities, projects, and special requests effectively.
  • Facilitate pFMEA activities to identify and mitigate process and manufacturing risks.
  • Build and sustain relationships with all functions, external partners, and suppliers to inform decisions regarding manufacturing processes.
  • Establish, monitor, and analyze key performance metrics to assess daily operations and identify improvement opportunities.

Qualifications

Essential skills and experiences include:

  • A Bachelor's or advanced degree in an engineering discipline, with at least 10 years of relevant experience in medical device engineering and manufacturing, particularly in diagnostic devices and consumables. Experience in other highly regulated sectors will also be considered.
  • A leader passionate about developing robust production processes.
  • A proven track record of managing complex projects from New Product Introduction (NPI) to mass production.
  • Capability to devise high-level production strategies while executing detailed plans.
  • Experience with plastic laser welding, CAD (Solidworks or Fusion), machining, and injection molding is highly desirable.
  • Strong problem-solving skills, a quality and customer-focused mindset, and a drive for success.
  • In-depth knowledge of high-volume manufacturing processes and failure analysis.
  • Extensive experience in data analysis and analytics, with a solid grasp of measurement control metrics including GR&R, Cp/Cpk, and correlation analysis.
  • Strong stakeholder management, data management, and process design skills.
  • Able to manage multiple projects simultaneously in a dynamic environment.
  • Experience leading and participating in cross-functional and/or global teams, fostering connections across different organizational areas.
  • Exceptional verbal and written communication skills.
  • Proven ability to make complex, time-sensitive decisions that align with organizational interests.
  • A self-motivated team player who can effectively resolve issues through strong problem-solving capabilities.

Core Values Alignment

  • People First: We prioritize our colleagues and customers, celebrating diversity and collective success.
  • Ownership Mindset: We take responsibility for our decisions and utilize resources judiciously.
  • Tenacity: As innovators, we embrace failure as a learning opportunity and persist through challenges.
  • Action-Oriented: We favor proactive approaches and rely on intuition when faced with uncertainty.
  • Smart Work: We focus on planning and adapting to achieve significant outcomes efficiently.
  • Transparency: We value openness and constructive feedback, maintaining honesty with ourselves and our customers.

Additional Information

We offer an array of benefits:

  • Comprehensive medical insurance, including dental and vision coverage.
  • Competitive salary structure reflecting our appreciation for our employees.
  • Equity opportunities, allowing every employee to share in our success.
  • Pre-tax commuter benefits to ease your travel.
  • 401k plan to support your retirement planning.
  • The chance to contribute to a groundbreaking healthcare product that impacts millions.

Detect is committed to equal opportunity employment, ensuring a diverse and inclusive workplace.

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