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Development Engineer III

3 months ago

Charlton MA United States KARL STORZ Endoscopy - America Full time

POSITION DESCRIPTION

 

This Development Engineer is responsible for project/design leadership of KS-PDI new product development projects. Primary responsibilities include development and upgrade of KARL STORZ products, both Medical and Industrial Flexible Endoscopes, including associated components and accessories, as well as the construction and testing of prototypes. The Engineer will lead international teams of engineers and technicians to assure on-time delivery of new products to the market. Additional responsibilities include manufacturing transition, process development, and test protocol development for flexible endoscopes from Concept to Pilot phases of projects. There is also a requirement to interface with production and technical personnel to completely document all phases of product testing and transition.

 

MINIMUM KNOWLEDGE, EDUCATION AND SKILL REQUIREMENTS
 

  • B.S degree in Mechanical Engineering or other with emphasis in mechanical design.

  • 6 years + of experience in a Design or Project Engineering environment

  • 3 years minimum of work experience in a medical product development environment

  • 2 years of project management experience a plus.

  • International communication skills preferred

  • Strong computer skills; Proficiency in SOLIDWORKS and Microsoft packages is required (Microsoft Word, Excel, MS Project/Server, etc.)

  • This position requires a thorough knowledge of standard engineering practices

  • Previous successful experience leading project teams and/or supervising technical employees

  • Tool shop experience is preferred 

 

ESSENTIAL FUNCTIONS

 

PHYSICAL REQUIREMENTS

                                   

  • Must be punctual, able to sustain attendance guidelines, and work hours as assigned

  • Should have sufficient visual capacity to make judgments concerning the quality of components, subassemblies and/or finished products

  • Ability to work with small parts and with computers for extended period of times

  • Must be able to work overtime as needed

 

 

MENTAL REQUIREMENTS

 

  • The ability to pay close attention to detail in a fast paced environment is essential

  • Must be able to analyze root causes of technical issues and apply lasting corrective action

  • Must be able to deal effectively with multiple changing priorities 

  • Ability to solve problems of diverse scope and high complexity within areas of responsibility

  • Mental stamina is required, as the majority of the day is spent at a computer screen

  • Has responsibility for decisions on own designs including selection of materials and purchased components to be used

  • Responsible for design time estimation and for subsequently keeping projects on schedule

  • Must demonstrate creative approaches to solving technical issues

  • Must be self-directed / self-starter

 

DUTIES AND RESPONSIBILITIES (Other duties consistent with the general nature and focus of the position and/or the goals and objectives of the department may be assigned.)

 

 

  • Design, test, and documentation, as well as manufacturing transition of Flexible Endoscopes

  • Understanding of processes and technology for product upgrades, improvements, and cost reduction are also important aspects of the position

  • Logging/record keeping of all work is required

  • Data manipulation and development / refinement of test protocols

  • Investigation of failures with corrective action recommendations as they relate to product returns

  • Development of prototype and manufacturing tooling is also an important aspect of the job

  • Serve as technical resource for manufacturability of designs, verify product performance to specifications

  • Must be an independent worker (with minimum direction), capable of meeting goals and objectives as defined by management

  • Act as a key contributor on regional and global project team

  • Regularly communicate with other KARL STORZ locations, both in the US and abroad regarding project updates

  • Evaluate changes in products per organizational risk management practices to ensure effective, safe and compliant devices are released to the market in accordance with current standards

 

ENVIRONMENT, HEALTH AND SAFETY:

 

  • Must be committed to a high standard of safety and be willing and able to comply with all environmental and safety laws and regulations, including the company’s environmental and safety policies and procedures; must be willing to report actual and potential environmental and safety violations to appropriate supervisory and/or management personnel.

  • Must not pose a direct threat or significant risk of substantial harm to the safety of himself/herself or others

  • Responsible for informing the company if he/she is taking medications or if there are any other circumstances that would interfere with safe performance of job duties

  • Responsible for acting on the information provided to him or her by subordinate employees by recording information and promptly pursuing resolution of any identified problems

 

 

​​​​​​​QUALITY

  • ​​​​​​​​​​​​​​The incumbent in this position is responsible for knowledge of and adherence to the company policies and procedures as they relate to the requirements of the KS Quality System

  • Notes and processes must conform to company standards (i.e. traceable and legible);  test data must be recorded, date stamped, and filed in an accessible manner

 

 

​​​​​​​INTERPERSONAL AND COMMUNICATION SKILLS

 

  • Must be able to maintain productive working relationships with co-workers

  • Must treat fellow employees with respect

  • Must be capable of communicating (both verbally and in writing) effectively with peers, subordinates, and superiors (within and outside the department), as well as with KARL STORZ customers in regard to product issues

  • Must prepare written reports in a professional manner

  • Must interact with all departments (globally) and lead teams to build consensus and resolve complex technical issues

  • Must express technical ideas clearly to engineering personnel, customers, and vendors

  • Must effectively work with a great variety of personalities in a great number of different departments

  • Above average presentation skills are required for inter-company meetings and design reviews

 

 

OTHER FUNCTIONS

 

OTHER DUTIES AND RESPONSIBILITIES (Other duties consistent with the general nature and focus of the position and/or the goals and objectives of the department may be assigned.)

 

  • Evaluates potential materials, procedures, and components for product improvement

  • Implement design changes into existing products

  • Technical support to all departments as required for assigned projects

  • Position requires up to 15% travel (Domestic and International)

 

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