- Contribute to the upkeep of the existing devices and manufacturing processes
- Execute product design changes for existing devices due to, but not limited to, CAPAs, product complaints, COGS reduction efforts, and component obsolescence
- Work in a cross functional team, collaborating with engineers, QA/RA specialists, marketing personnel, and manufacturing employees for life-cycle projects
- Contribute to the registration efforts of existing devices for the EU market
- Create and maintain documentation for product specific DHF (design history files) and DMR (device master records)
- Maintain technical drawings for product components and assemblies
- Manage engineering change requests related to product design changes
- Improve manufacturing processes and fixtures for assembly of existing devices
- Improve inspection procedures for quality control of existing components and assemblies
- Create process validation protocols and reports, conducting hands-on testing to gather applicable data
- Ensure the compliance of the design controls procedure, by working closely with regulatory personnel during design change activities
- Identify and implement improvements to established products and processes, by working closely with regulatory and manufacturing personnel
- Preparation and participation in internal and external audits
- Provide technical input to marketing and regulatory personnel regarding projects within your work cell
- Oversee technical issues with component suppliers
- Create project schedules in the form of Gantt charts and action item lists
- Provide accurate completion date and remaining work estimates for project managers
- Communicate on the progress of projects
- Other duties may be assigned
- Experience with design and development processes
- Experience with design change processes
- Experience with drafting/CAD software, preferably SolidWorks
- Experience with DHFs and DMRs
- Proficiency in Microsoft Office applications, including Word and Excel
- Great attention to detail, especially proofreading of documentation prior to submittal
- Strong organizational skills
- Ability to multi-task on different projects, while maintaining high quality performance
- Strong communication skills, both written and spoken
- Ability to work cross-functionally with a team, including engineering, regulatory, marketing, and manufacturing personnel
- Ability to problem solve and think outside of the box
- The desire to be hands-on and involved through the entire process
- Proficient at technical problem-solving
- Proficient in technical writing
- Knowledge and experience of engineering change-management processes
- 1 years of industry engineering experience required (relevant internships/co-ops will be considered in place of industry experience)
- Bachelor's degree in engineering, preferably in mechanical, manufacturing, or biomedical engineering
- Medical
- Vision
- Dental
- 401k Matching
- Employee Assistance Programs
- Vacation and sick pay
- The list goes on
Life-cycle Engineer, Associate - Chester, United States - ZEISS Group
Description
About Us:
How many companies can say they've been in business for over 177 years?
Here at ZEISS, we certainly can As the pioneers of science, ZEISS handles the everchanging environments in a fast-paced world, meeting it with cutting edge of technologies and continuous advancements. ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change. We have a diverse range of portfolios throughout the ZEISS family in segments like, Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 42,000 employees and have over 4,000 in the US and Canada alone Make a difference, come join the team
What's the role?
As part of R&D, apply fundamental engineering skills to complete life-cycle development activities for existing products within the ophthalmic and neurosurgical device portfolios
Sound Interesting?
Here's what you'll do:
Do you qualify?
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, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
We have amazing benefits to support you as an employee at ZEISS
ZEISS is an EEO/AA/M/F/Disabled Veteran Employer
Your ZEISS Recruiting Team:
Clara Cresswell