Lead Process Engineering Specialist

2 weeks ago

Guilford, Connecticut, United States Detect Full time

Company Overview

At Detect, our mission is to democratize accurate diagnostics. We are pioneering innovative technology that merges software, hardware, chemistry, and biology to ensure diagnostics are accessible wherever they are 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 Lead Process Engineering Specialist 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 methodologies for high-volume consumables and prototype systems at our headquarters.

The ideal candidate will be a versatile and proactive individual – self-driven, detail-oriented, and collaborative, possessing a comprehensive understanding of technical and manufacturing principles, alongside exceptional communication skills. Success in this position will necessitate a combination of strategic foresight and hands-on involvement. Experience in formulating 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).
  • Develop, produce, and validate manufacturing fixtures, plastic laser welding processes, and production testing platforms.
  • Collaborate with cross-functional teams including R&D, engineering, and operations to support manufacturing initiatives.
  • Organize and prioritize tasks with minimal oversight, managing projects and special requests effectively and timely.
  • Lead pFMEA sessions to identify process and manufacturing challenges and mitigate associated risks.
  • Establish and nurture relationships with all functions, external partners, and suppliers to make informed decisions regarding manufacturing processes.
  • Set, monitor, and analyze key performance metrics to evaluate day-to-day operations and identify improvement opportunities.

Qualifications

Essential skills and experiences include:

  • A Bachelor's or advanced degree in an engineering discipline, accompanied by 10 years of relevant experience in medical device engineering and manufacturing, ideally within diagnostic devices and consumables. Experience in other highly regulated sectors will also be considered.
  • A leader passionate about all facets of developing robust production processes.
  • A proven track record of managing complex projects from New Product Introduction (NPI) to mass production.
  • Capability to formulate high-level production strategies while executing the finer details of the plan.
  • Experience with plastic laser welding, CAD (Solidworks or Fusion), machining, and injection molding is highly desirable.
  • Strong problem-solving abilities, a quality and customer-focused mindset, and a personal drive for success.
  • Comprehensive knowledge of high-volume manufacturing processes and failure analysis.
  • Extensive expertise in data analysis and analytics, with a solid grasp of measurement control metrics including GR&R, Cp/Cpk, and correlation analysis.
  • Strong stakeholder management skills, adept in data/information management and process design.
  • Ability to juggle multiple projects in a fast-paced environment.
  • Experience leading and participating in cross-functional and/or global teams, effectively connecting with colleagues across various organizational areas.
  • Exceptional verbal and written communication capabilities.
  • Demonstrated ability to make complex, time-sensitive decisions in the organization's best interest.
  • A self-motivated team player who can drive issue resolution with strong problem-solving skills.

Core Values at Detect:

  • People First: We prioritize our colleagues and customers, celebrating diversity and shared success.
  • Ownership Mindset: We take responsibility for our decisions and treat company resources as our own.
  • Tenacity: As innovators, we embrace failure as a part of the process and persist through challenges.
  • Action-Oriented: We are proactive and trust our intuition, even with incomplete information.
  • Smart Work: We focus on planning and adjusting to achieve significant outcomes efficiently.
  • Transparency: We value openness and diverse opinions, providing honest and compassionate feedback.

Additional Information

We offer a range of benefits:

  • Comprehensive medical insurance, including dental and vision coverage, reflecting our commitment to employee well-being.
  • Competitive salary packages, demonstrating our appreciation for our team members.
  • Equity opportunities, ensuring every employee has a stake in our success.
  • Pre-tax commuter benefits to ease your daily travel.
  • A 401k plan to support your retirement planning.
  • The chance to contribute to a groundbreaking healthcare product that can transform millions of lives.

Detect is an equal opportunity employer, committed to diversity and inclusion in the workplace. All information will be kept confidential according to EEO guidelines.

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