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Development Engineer - NiTi

Date: Jul 19, 2021

Location: Concord - California, US, 94520

Company: Heraeus

[title]
Development Engineer - NiTi
Heraeus Medical Components
Location Concord - California
Permanent  
Full Time
 
 

Position Title:

Development Engineer

Department:

Engineering

Reports To:

Development Manager, Director or Project Engineer

FLSA Status:

P

PA

Exempt

F/P Time:

 

Full time

Location:

 

 

 

Concord, CA

 

HMC Overview

 

Heraeus, the technology group headquartered in Hanau, Germany, is a leading international family-owned company formed in 1851. With expertise, a focus on innovations, operational excellence, and an entrepreneurial leadership, we strive to continuously improve the businesses of our customers around the world.

 

Summary

This position is for an experienced engineer engaged in design and product development of medical components and assemblies.  This individual will be responsible for owning the process from development through production including tooling design, process capability, process quality deliverables, and process cost and technology improvements. Understands process characterization tools and uses them as needed across various technologies.  Experience with NiTi medical devices.  This will be a position filled with variety including some hands-on, customer interface, and many strategic technical elements.

 

 

Essential Duties and Responsibilities

 

  • As a Development Engineer, support Design and Development Project for Medical Products and Processes in accordance with company goals.
  • As a Development Engineer, execute deliverables for Design Control process to deliver the desired product to production in a cost effective manner while hitting product performance and profitability goals; project responsibilities will include support in production until product meets intended profitability and quality targets.
  • Responsible for part review at design and quote stage based on project need and process knowledge.
  • Involved in prototyping, process development, confirmation runs, and validation. Available to support and trouble shoot production issues as needed.
  • Assume responsibility for completeness and accuracy of developed processes (i.e., lead, manage, communicate, complete documentation, train) including ownership of process capability, process quality, and process costs.
  • Collaborate cross functionally to ensure alignment with all stake holders.
  • Work with development and production operators and technicians on new and revised processes.
  • Assist in new equipment identification, procurement, installation qualification, document creation, and training. May participate in execution of these activities as needed.
  • Coordinate new tooling/fixturing identification, procurement, and verification. May participate in execution of these activities as needed.
  • Identify new technologies in accordance with site and customer priorities to improve efficiency, quality, reduce costs, and meet market technology needs.
  • Demonstrate and utilize tried and true Engineering methods and resources to streamline the development process.
  • Use statistical tools to analyze data, make development decisions, and improve process capability (Six Sigma, SPC, DOE).
  • Work with manufacturing & quality engineering, business development and production management to establish, implement and deliver products to production that meet their design and profitability targets within the first 3 months of release to production.
  • Design Control / Process Validation within the requirements of our procedures.
  • Communicate verbally/written pertinent information to management and to customers.
  • Assist in the development of in-process quality manufacturing practices to support development projects.
  • Ensure technical accomplishments and other testing is fully documented for reference and traceability through company systems.
  • Additional duties as assigned or apparent.

 

 

 

 

Administrative Responsibilities:

  • Develop and monitor quarterly goals.
  • Provide periodic more formal updates on progress of projects.
  • Participate in company meetings and training sessions.

 

Qualifications

 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, ability and/or travel availability required.

 

  • Product or Process Development Engineering experience in a regulated environment and demonstrated competence in required documentation and industry accepted practices
  • Knowledge and experience with Design Control and Process Validation documentation
  • Knowledge of and effective application of engineering tools (e.g., DOE, SPC, Process Validation)
  • Knowledge of clinical applications for interventional medical procedures
  • Knowledge of Development for Lean Manufacturing experience a plus

 

Skills:

  • Skills and experience in developing medical components for a variety of procedures.  Knowledge of NiTi forming/ shape setting and electropolishing
  • Highly effective communication and technical writing skills.  Demonstrated computer literacy and competency.
  • Demonstrated skills in successfully working with Customers through verbal and written communications; project leadership skills with Customer representatives on the team will be important
  • Ability to solve complex engineering problems through the effective use of available resources, colleagues, and 3rd parties.
  • Demonstrated skills in prototyping and design for manufacturability practices

 

Personal Approach:

  • A person of integrity that makes commitments thoughtfully and takes them seriously.  This person will do whatever is reasonable to deliver excellence on those commitments
  • This person will be principled in the importance of agile, yet effective documentation of their work in accordance with regulatory and procedural requirements.
  • Collaborative style of work; embracing the value of cross-functional groups and an open communications style in good times and in times of challenge
  • Practical and “as simple as possible” approach to Engineering and a partnering style with colleagues in all functions in the business
  • Optimistic approach to challenges – “can do” style
  • Highly communicative, thorough and concise in doing so

 

 

 

Education and/or Experience

 

  • B.S. in Engineering or Related Technical Field strongly preferred
  • 2+ years’ Engineering Experience preferred (NiTi experience a plus)

 

 

Work Environment

 

Office Setting

 

 

Position type and expected hours of work

 

Full time. Overtime as required.

 

 

Travel

 

Percentage of travel time may be expected for this position, both locally or in specified countries or states.

 

 

Work Environment

 

While performing the duties of this position, the employee is occasionally exposed to moving mechanical parts as well as hazardous materials/chemicals.  The noise level in the office environment is usually quiet to moderate. This person will be required as needed to wear Specialized Protective or Safety Equipment such as Safety Shoes, Eye Protection, Hearing Protection, or Breathing Apparatus.  While performing the duties of this position, the incumbent may be in contact with potentially hazardous materials.

 

Safety/Security/Environmental

 

  • Maintain a clean, safe work area in compliance with OSHA standards.
  • Maintain awareness and compliance with all current local, state, and federal Environmental regulations, such as all regulations governing the handling and disposal of Hazardous waste.
  • Comply with all Security policies as outlined by the company standards and local, state and federal laws, as well as Heraeus Safety policies.

 

Other

 

As provided by the Americans with Disabilities Act, the company is committed to discussing and providing reasonable accommodations to its employees to help them fulfill the essential functions of their jobs.

 


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Nearest Secondary Market: Oakland