Development Engineer IV

I. POSITION DESCRIPTION

This Development Engineer is responsible for project/design leadership of KARL STORZ product development and maintaining 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 production of projects. There is also a requirement to interface with production and technical personnel to completely document all phases of product testing and transition.

II. MINIMUM KNOWLEDGE, EDUCATION AND SKILL REQUIREMENTS

• B.S degree in Mechanical Engineering (or equivalent mechanical design based degree).
• 9 years + of Experience in a Design or Project Engineering Environment
• 5 years + of Work Experience in a Medical Product Development Environment
• Project management experience a plus.
• Strong Computer Skills; Proficiency in SolidWorks, Statical Analysis, and Microsoft packages is required (Microsoft Word, Excel, MS Project/Server, etc.)
• Familiarity with global development procedures and standards for medical devices and projects is preferred.
• This position requires a thorough knowledge of standard engineering practices.
• Previous successful experience leading project teams and/or supervising technical employees is required.
• Prototype fabrication, and machine shop experience is preferred.

III. ESSENTIAL FUNCTIONS

1. PHYSICAL REQUIREMENTS

• Must be punctual, able to sustain attendance guidelines, and work hours as assigned.
• Must have sufficient visual capacity to make judgments concerning the quality of components, subassemblies and/or finished products.
• Must be able to build and test designs and concepts developed.
• Must be ability to work with small parts and with computers for extended period of times.
• Must be able to work overtime as needed.
• Travel domestically and internationally as necessary.
• Driving on company business is required as part of this job.

1. 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.
• Mental stamina is required as it is often necessary to spend extended periods of time working on a computer.
• Must be able to weigh in on and make critical decisions on designs including selection of materials and purchased components to be used.
• Is responsible for design, and prototype build time estimation to ensure projects are kept on schedule and within budget.
• Must demonstrate creative approaches to solving technical issues.
• Must be self-directed / self-starter.

1. 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.)

• The designing, prototyping, testing, documentation, and manufacturing transition of new product designs often within the companies Flexible Endoscope portfolio.
• The execution of processes improvements and design upgrades for existing products within the company’s portfolio. These upgrades often focus around performance improvement, production yield and cost reduction.
• Development to testing protocols along with execution and data analysis is required.
• Accurate and clear logging/record keeping of all work is required.
• Must be able to produce full design packages for all new design and existing design changes. These packages include but are not limited to full CAD (SolidWorks) Drawings/Assemblies, Tolerance Stack Analysis, and testing data.
• Investigation of failures of product both in development and returning from the field. The investigation often will require the implementation of a corrective action which may be led by an individual in this position.
• Must be capable of developing and building of prototypes of designs along with any manufacturing tooling that is required for complex assemblies.
• Must be an independent worker (with minimum direction), capable of meeting goals and objectives as defined by management.
• Act as a key contributor on local and global research and development efforts.
• Evaluate changes in products to ensure effective, safe and compliant devices are released to the market in accordance with current standards.
• Team Lead / Supervisory duties may also be required.

D. 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.
• The incumbent in this position is responsible for knowledge of and adherence to environmental policies and company procedures as they relate to ISO 14001.
• 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.
• Other specific safety responsibilities include the development of device assembly procedures that are safe for co-workers.
• Specific safety hazards associated with this job include the use of chemicals, solvents, and machine tools.

1. QUALITY

• The incumbent in this position is responsible for knowledge of and adherence to all company policies and procedures. Such as but not limited to those that relate to the requirements of the internal KS Quality Systems along with FDA Quality System Regulation, ISO 13485 and ISO 9001 (current revisions).
• 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.

1. INTERPERSONAL AND COMMUNICATION SKILLS

• Must exhibit strong leadership skills and be able to supervise technical employees.
• 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 clear, concise, and professional manner.
• Must express technical ideas clearly to engineering personnel, customers, and vendors.
• Must interact effectively with all departments (globally) and lead teams to build consensus and resolve complex technical issues.
• Must have good presentation skills for inter-company technical meetings and design reviews.

IV. OTHER FUNCTIONS

A . 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 20% travel (Domestic and International)