Job Description

Design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality, Support new product transfers to manufacturing.

To perform this job successfully, an individual must be able to perform each essential job task satisfactorily. The tasks listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Design and develop manufacturing processes for new products, product changes and enhancements, and related tooling and fixtures which are consistent with a zero defect level as well as low product cost.
• Investigate benefits and features of capital equipment and generate capital appropriation justifications.
• Create and maintain accurate documentation of concepts, designs concepts, tool drawings and shop orders in coordination with the Quality Assurance and R&D functions.
• Perform Installation Qualification (IQ) equipment protocols and reports.
• Provide engineering support to production department in troubleshooting and resolving technical problems.
• Coordinate work with outside vendors, assigned technicians and tool room personnel.
• Plan and schedule projects in a manner consistent with corporate objective.
• Contribute to the intellectual property position of the company via invention and patent applications.
• Maintain accurate documentation of concepts, designs, and processes.
• Maintain current knowledge of medical, technical, and biomedical developments as related to company products.
• Support prototype and pilot production of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.
• Provide engineering support to production department in troubleshooting and resolving technical problems.
• Work with new product development staff to ensure that new manufacturing processes are designed for manufacturability, help resolve issues.
• Maintain GMP compliance in coordination with the Document Control, R&D, and Quality Assurance functions
• Complete accurate and timely manufacturing documentation including manufacturing procedures, materials records, etc.
• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
• Ensure that all regulatory and internal policies are followed.
• Identifies hazards and mitigates risk associated with identified hazards in Process FMEA.

• Perform other duties as assigned by supervisor.

  QUALIFICATIONS

  · Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
  · Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
  · May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel.
  · Utilizes Solid Works drafting skills when appropriate
  Minimum Education: · Requires a Bachelor degree or equivalent in engineering or related discipline.
  · Masters preferred
  
  Minimum Experience: · Requires a minimum of 2 years related experience.

   

  Specific Skills, Knowledge & Behaviors ( To perform the job successfully, an individual should demonstrate the following competencies):
   
  Core Competencies:
  ·  Interpersonal Effectiveness: Actively seeks to understand perspectives and interpersonal needs and expectations of others at all levels, builds self-awareness, flexes personal style appropriately, and works through conflicts constructively and appropriately
  ·  Communication: Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills
  ·  Collaboration & Teamwork: Actively works together with formal and informal team members to build relationships and achieve team goals
  ·  Prioritization: Effectively prioritizes work to ensure timely completion of work within scope
  ·  Global & Systems Thinking: Continuously seeks to learn about and embrace global nuances, works across functions and geographies, seeks to align with diverse groups, and seeks to understand interdependencies and impacts of actions across functions and the company
  ·  Technical Expertise: Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope
  ·  Continuous Improvement: Learns and uses best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self
  ·  Problem Solving & Problem Prevention: Learns and uses strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention
  ·  Accountability: Focuses on results, takes initiative without direction, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility
  
  Equipment Use & Abilities Required: ·  Equipment Use: Copy machines, fax machines, calculators and personal computers and computer terminals.
  ·  Computer Skills: Software proficiency in Microsoft Office Suite.
  ·  Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, legal documents or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. 
  ·  Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. 
  ·  Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form 
  WORK ENVIRONMENT & PHYSICAL DEMANDS OF THE JOB:

  The noise level in the work environment is usually quiet. While performing the duties of this job, the employee is regularly required to sit; use hands and fingers; talk or hear. The employee is occasionally required to reach with hands and arms and to move within and between the buildings. A computer terminal is used to access, input, and retrieve data. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision.
  

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