Job Description:
We are currently seeking an experienced, extremely capable, self-motivated, and personable Manufacturing Engineer to oversee and improve the quality and scalability of production processes. This wide-ranging, hands-on position includes everything from making our production processes and tools more efficient, interfacing with our contract manufacturers, performing root cause analysis, selecting alternative components due to end of life or out of stock, ECO management, launching new products, or even designing electromechanical changes.
In this role you will ensure that all manufactured products meet the required standards for quality specifications and may lead investigations, resolve potential product quality issues, or make recommendations for improvement. Most important you will lead best practice in hardware development and manufacturing.
Responsibilities:
- Build on relationships with our Quality partners at CMOs ensuring quality issues are tracked and resolved in a timely manner.
- Work with our CM to promote continuous improvement methods to include defect containment, root cause analysis, and internal / external corrective actions.
- Develop and implementing optimal, cost effective manufacturing processes and methods in accordance with product specifications and quality standards.
- Ensures that effective corrective and preventive actions are instituted in a timely manner to prevent reoccurrence of quality events in production.
- Review and approve: Test history files in support of product release; Standard Operating Procedures, test methods, and work instructions. Ensuring they are current and accurate.
- Supports regulatory inspections and file updates (TUV/CE)
- Ensures testability of requirements and test coverage.
- Design and implement hardware engineering changes to eliminate defects, improve efficiencies, or expand our product offering.
- Lead DFM/DFA activities for new products or new product development projects.
- Assist in the development of filed service docs that pertain to new or existing hardware design.
- Collaborate with sales, purchasing and other production groups to ensure that production resources and materials match market demands and sales requirements.
Education/Experience:
- Bachelor’s Degree in Engineering – electrical, mechanical or equivalent experience in manufacturing.
- Experience with SolidWorks or Altium
- 3-5 Years of Electro-Mechanical Manufacturing experience
- BOM management and lifecycle management experience.
- Experience with managing outside suppliers and contract manufacturers is a plus.
- Six Sigma Certified is a plus
- Experience with programming and script writing is a plus
- Experience with ISO9001, CE, and TUV would be a plus
- Relevant experience in a regulated biotech or pharmaceutical industry is a plus
- Experience supporting automation equipment in a laboratory setting is a plus
Skills:
- Excellent attention to detail, project and time management skills, and the ability to manage multiple competing priorities with aggressive timelines.
- Ability to effectively communicate verbally and in writing, make presentations with customers, subcontractors, and vendors.
- Demonstrated successes in leading projects to drive process optimization, quality improvement, product expansion, or cycle time reduction.
- Strong organizational, analytical, and problem solving skills
- Hands-on experience supporting automated assembly equipment
- Demonstrates flexibility and excels within a fast-paced environment with changing priorities.
- Be a team player, positive influence on others, and should strive to learn, improve, and grow within the company.
- While performing the duties of this position the employee is regularly required to sit and talk and hear. The employee is regularly required to use hands to finger, handle or feel and reach with hands and arms. The employee is required to stand, walk, and drive or ride in a motor vehicle. Must be able to lift a minimum of 70 lbs. This position requires a considerable amount of pushing, pulling, stooping, bending and lifting. Must have the ability to travel, sometimes with short notice and be able to provide after-hours weekend support as needed.