Sr. Manufacturing Engineer

SUMMARY:

Our Implantables & Consumables division is a leading contract manufacturer for medical and combination devices. We work side-by-side with our customers in the development of the manufacturing process of new products. During the multi-year relationship with our customers, we increase manufacturability by implementing custom automation designed and built in-house, produce batches for testing phases, and ensure compliance with all regulatory bodies required for the production of Medical Devices, Combination Devices, and Pharmaceuticals.

As a Manufacturing Engineer you will aide in streamlining our manufacturing process. Our ideal candidate will have a passion for manufacturing with a background in medical device, pharmaceutical or regulated manufacturing industry experience.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Assist in the development and qualification of Medical Device and Industrial productions
• Evaluate manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators.
• Develop manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors.
• Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
• Assure product and process quality by designing testing methods; testing finished goods, determining product and process capabilities; establishing standards; confirming manufacturing processes.
• Provide manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements.
• Prepare product and process reports by collecting, analyzing, and summarizing information and trends.
• Provide manufacturing engineering information by answering questions and requests.
• Maintain product and company reputation by complying with FDA and ISO13485 regulations.
• Keep equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service.
• Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
• Apply FMEA process to evaluate failure data, if necessary, from field data to find root cause and implement sound engineering solutions.
• Support validation in all manufacturing processes per FDA requirements for medical equipment.

QUALIFICATIONS:

To perform this job successfully, the 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.

• A Bachelor of Science in Engineering.

• A minimum of 2 years of experience as a Manufacturing Engineer

• Medical device, combination device, pharmaceutical, or other regulated product manufacturing experience.
• Experience with Lean Manufacturing and Six Sigma principles including DMAIC, The 5 Why's, 5S, Value Stream Mapping, Regression Analysis, FMEA, Kaizen, Gage R&R, etc.
• Experience with Root Cause & Corrective Action principles.
• Strong written and verbal communication skills in the English language.
• Experience with MS Windows operating system and products.
• Experience in applying advanced mathematics, and algebra skills.
• Experience with automated production lines is preferred.