Our client is a well-established, global manufacturer of medical devices with special emphasis on electro-mechanical and cardiovascular products.
This position is responsible for investigating, planning, and implementing the more complex improvements in and/or additions to current products and manufacturing processes that directly affects safety, quality, and productivity with the end result of producing a better quality product more efficiently. Involved with leading projects of moderate scope requiring engineering team effort or a multi-discipline team effort. Considered the technical expert in his/her area of engineering. Assigns and assists in providing engineering related duties or projects to lower level engineers, designers, and technicians. Ensure compliance to the Company's quality policy, respond to customer complaints, perform audits, develop test methods, and/or write procedures for material characterization
- Full Time Permanent Position
- Relocation Assistance Available
- Minimum Experience; 3 to 5 years in related area
KEY OBJECTIVES and DELIVERABLES:
Maintain and follow proper ISO procedures and GMP requirements;
- Provide technical assistance and leadership required to plan and implement projects to develop, install, and qualify new products, and/or new processes for manufacturing new products or for improving existing processes according to business plan objectives;
- Provide engineering expertise in the design, fabrication, development, installation, validation and qualification of equipment / product which may include feasibility studies and/or proper documentation for justification of project and training to ensure proper operation of the equipment;
- Monitor and control programs, identify issues and ensure they are resolved;
- Ensure proper documentation is prepared or corrected to reflect any changes implemented;
- Research and implement cost reduction projects, lines, extensions, and/or products;
- Provides assistance to production as required;
- Plan work schedules, expenditures, attend meetings, and prepare monthly reports as required, ensuring effective communication of ideas, information, and issues to appropriate stakeholders;
- Assign, delegate and assist in the completion of engineering tasks or projects to lower level engineers.
MINIMUM CANDIDATE REQUIREMENTS:
Requires a four year degree in an engineering curriculum. PhD (R&D positions) in appropriate engineering discipline and prior supervisory/project leadership experience preferred.
Minimum 6 years increasing responsibility and experience within a manufacturing environment; designing, specifying, fabricating, assembling, validating and debugging machinery / product and manufacturing processes.
Must have current working knowledge and understanding of the technologies, patents, and competition in designated areas of engineering expertise required.
Knowledge of GMP/FDA regulations.
- Thorough knowledge of statistical techniques / methods, engineering drafting and personal computers. Excellent communication skills both verbal and written.
ADDITIONAL SKILLS & EXPERIENCE PREFERENCES:
- Knowledge in finance to work with and understand general cost accounting principles preferred.
- Ability to create and work from engineering drawings and/or specs of particular engineering discipline.
- Excellent analytical and problem solving skills.
- Ability to lead project work.
- Thorough knowledge of electronic / chemical equipment and tools used in laboratory testing and inspection systems.
- Thorough knowledge of hydraulic, pneumatic, and electrical circuits as appropriate.
- Appropriate certifications for particular engineering discipline required.