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Head of Instrumentation Engineering

Organization

Resilience

Job Location

9310 Athena Circle
La Jolla, CA 92037
United States

Job Description

Role

The Head of Instrument Engineering will be collaborating with others in Resilience to develop instrumentation solutions, where you will architect, develop, and test our in-house instrument development supporting personalized medicine.  This role will be a key team contributor applying extensive knowledge of design principles and practices in implementing complex instrumentation and robotic solutions. General responsibilities include design concept generation, participating in and leading design reviews, developing and testing the product stack. This is a high-impact technical lead role where you will collaborate across engineering teams and provides an opportunity to lead the architecture and roadmap and coach engineering (mechanical, electrical, fluidics, optical) managers in the execution and development of instrumentation solutions.

 

Job Responsibilities

  • Provide strategic and technical leadership to the Instrument Engineering organization and drive innovative solutions for personalized medicine manufacturing
  • Drive early innovative technical development of modular components in the engineering fields of microfluidics, optics, automation, and electrical sensors.
  • Architect instrument and robotic solutions that leverage modular components towards an integrated automated solution.
  • Analyze the data from current Manufacturing Operations to review trends, opportunities for improvement and implement changes continuously.
  • Apply the best engineering practices in design, analysis, simulation, integration & test, and documentation in all engineering subject areas.
  • Recruit, hire, and coach instrumentation teams.
  • Establish group and individual objectives, priorities, and metrics to:
    • Create New Product Development goals and objectives.
    • Identify and create reliability and efficiency improvements of existing products.
  • Contribute towards instrumentation and engineering strategy.
    • Structure Bill of Materials (BOM’s) including strategy for sub-assemblies
    • Define and develop all required manufacturing processes (Equipment, Manufacturing Instructions, Travelers / Routers, etc.)
    • Specify, design, document, build and qualify the equipment necessary to perform each process step while providing necessary manufacturing capacity.
  • Maintain compliance with medical device (ISO13485) and Good Automated Manufacturing Practice (GAMP) quality system, including corrective action closure, discrepant material disposition, an Engineering Change Order (ECO) implementation.
  • Plan, budget, and staff projects, tracking performance throughout.
  • Work with Quality Engineering group to ensure that the team follows appropriate GMP, design history file (DHF), device history record (DHR) guidelines per FDA requirements, and support design reviews according to product development procedures.
  • Maintain the highest standards of excellence, never settling for the status quo

 

Qualifications

  • Ability to motivate, mentor, and inspire a high-capacity technical team.
  • Experience developing products from early-stage concept to volume manufacturing.
  • Prior experience in medical device manufacturing/field data analytics is a plus.
  • Knowledge of a wide range of manufacturing processes, such as machining, injection molding, MIM, laser welding, soldering, extrusion, crimping, and other forms of joinery.
  • Strong quantitative process development skills, including (p)FMEA, tolerance analysis, DoE, SPC, GR&R, and CpK.
  • Familiarity with mechanical CAD software (Solidworks).
  • Excellent organizational skills; Able to manage multiple fast-paced projects simultaneously.
  • Ability to communicate effectively and professionally across various technical disciplines with a broad slate of stakeholders, including management, peers, customers, and suppliers.
  • The initiative, curiosity, a bias for action, and a problem-solving attitude, and desire to bring innovative, simplified solutions to complex problems
  • Some background knowledge in computational biology, immunology, wet-lab experimental procedures, and data analysis is a plus.

 

Preferred Experience

  • BSc/MS: 15+ years of experience or Ph.D.: 12+ years of experience in a quantitative field, e.g., computer science, mechanical, or electrical engineering
  • Minimum of 8 years experience managing an engineering team.
  • Minimum of 10 years experience in an instrumentation development environment for complex electro-mechanical products.
  • Prior responsibility conducting Equipment Qualifications (IQ/OQ/PQ) and Process Validations.
  • Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment preferred
  • Prior experience with the Design Control processes for medical devices and clinical application of instruments is a plus.
  • Experience with machine control, robotic control, instrumentation, microfluidics, and/or medical device development under GAMP/GxP or FDA regulations preferred.

About Our Organization

RESILIENCE (National Resilience, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.

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