Senior Engineer, Manufacturing

The Senior Engineer, Manufacturing will own and drive process improvements through adherence to established design control processes, good engineering and documentation practices. The key responsibility of this position is to exercise judgement and take action while adhering to defined procedures during project support & improvements.  The Senior Engineer will complete advanced engineering projects with peer input and guidance from engineering management. They are a specialist on complex technical and business matters. Their work is highly independent, and they may assume a team lead role for the work group.

Essential Duties & Responsibilities

• Immediate expectations
  • Initiate and manage projects with adherence to program-management guidelines
  • Own and manage CAPA tasks and deliverables (Corrective and Preventive)
  • Lead vendor assessment and review of materials/machine technical information
  • Identify and implement process and product modifications to improve manufacturability and impact on automation equipment
  • Consult with Product and Molding Engineers on in-process non-conformances
  • Process technical expert for multiple manufacturing production lines
  • Create and edit documents to support Production
  • Work with Quality Engineers on qualification activities for new or modified processes and equipment
  • Receives general project direction. Responsible for project progress.
  • Analyzes, plans, organizes and completes projects of a very complex nature. Develops scope and provides creative solutions. Plans, organizes and conducts technical projects. Consolidates results of design elements of major projects for purpose of design review. Integrates subsystems and components in total systems design. Develops specifications from customer requirements.
  • Work on special projects as they arise
  • Decisions consistently affect multiple or critical projects in the business and may impact external relationships.
  • Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration. Brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively; builds consensus
• Long term expectations
  • Spearhead initiatives for continuous process improvements
  • Develop a broad understanding from start to end of the product manufacturing process in the company
  • Perform design assessments, active participation in design reviews and risk management processes
  • Network with senior internal and external personnel
  • Manages training new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures. May routinely monitor or supervise the work of one or more employees. Provides input on performance evaluations to area manager.

Knowledge & Skills

• Substantial knowledge in one or more key process areas: automation, medical-device assembly, controls, etc
• Understanding of strength of materials, plastic injection molding, fixturing, testing, and process control techniques
• Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.)
• Knowledge of the Medical Device Industry and familiarity with FDA QSR regulations
• Solid works knowledge to interpret part dimensions, sectional views, conduct mates and build assemblies
• Technical writing competency
• Has mastered best practices.  Has an advanced understanding of engineering discipline
• Can assess what work supports the product strategy and make insightful recommendations regarding priorities
• Expert in your domain of expertise.  Familiar in other areas of domain expertise within the team.

Minimum Qualifications, Education & Experience 

• Must be at least 18 years of age
• Bachelor's degree from an accredited college or university (Engineering or Technology)
• 7+ years of experience

Work Environment

• This job operates in a professional office environment and routinely uses standard office equipment 
• Work is performed in a clean room environment.  
• While performing the duties of this job, the employee is regularly required to work with contaminated Medical Devices in a controlled laboratory setting
•  Must be able to occasionally move objects up to 15 lbs.