Senior Manufacturing Process Engineer
2 weeks ago
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 right where they are needed. Our overarching aim is to reduce healthcare expenses, enhance patient outcomes, and improve the experience for healthcare providers by facilitating earlier diagnoses and access to treatment.
Position Overview
Detect is in search of an onsite Lead Process Engineering Specialist / Senior Manufacturing Process Engineer 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 exceptional communication skills. Success in this position will necessitate a combination of strategic foresight and hands-on involvement. Experience in creating production processes within an ISO-13485 / GMP environment 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 execute equipment and process validation activities (IQ/OQ/PQ).
- Develop, 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.
- Lead pFMEA initiatives to identify and mitigate process and manufacturing risks.
- Foster and maintain relationships with all functions, external partners, and suppliers to inform decisions regarding manufacturing processes.
- Establish, monitor, and analyze key performance metrics for daily operations and identify opportunities for enhancement.
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 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 successfully delivering complex projects from New Product Introduction (NPI) to mass production.
- Capability to devise high-level production strategies while executing the finer details of those plans.
- 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.
- 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 internal stakeholder management, data management, and process design skills.
- Ability to manage multiple projects simultaneously in a dynamic 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 resolution to challenges with strong problem-solving skills.
Core Values Alignment
We seek individuals who resonate deeply with our core values:
- Prioritize People. Our colleagues and customers are our top priority. We respect and celebrate our diversity, sharing in each other's successes and facing challenges as a united team.
- Ownership Mindset. We take responsibility for our decisions and actions. We are resourceful and treat company resources as if they were our own.
- Resilience in Innovation. As innovators, we embrace failure as a learning opportunity. We are persistent and find solutions to challenges.
- Action-Oriented. We are proactive and encourage individual contributions, trusting our instincts even with incomplete information.
- Smart and Fast Execution. We are inventors who focus on planning and adapting to achieve significant outcomes efficiently.
- Transparency and Honesty. We value openness and diverse opinions, providing candid feedback while remaining compassionate.
Additional Benefits
We offer a range of attractive benefits:
- Comprehensive medical insurance, along with dental and vision coverage, reflecting our commitment to employee well-being.
- Competitive salary, demonstrating our appreciation for our employees.
- Equity opportunities, ensuring every employee has a stake 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 will positively impact millions.
We provide visa assistance for qualified candidates.
Detect is an equal opportunity employer, committed to diversity and inclusion. All information will be kept confidential in accordance with EEO guidelines.
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