What are the responsibilities and job description for the Senior Manufacturing Engineer position at Intellectt Inc?
Job Title: Senior Manufacturing Engineer
Location: Beverly, MA
Duration: Full Time
Job Description:
Essential Functions:
- The incumbent may be required to perform all or a combination of the following essential functions as determined by business necessity.
- Perform and report on evaluation testing, verification and validation in accordance with ISO, FDA and corporate guidelines.
- Estimate production times, staffing requirements, and related costs to provide information for management decisions.
- Confers with management and other staff regarding manufacturing capabilities, production schedules and other considerations to facilitate production processes.
- Apply statistical methods to troubleshoot processes and conduct root cause analysis.
- Improve existing operations, incorporating new methods, processes and training.
- Handle equipment purchase and installation, perform IQ/OQ and PQ functions.
- Investigate operational problems affecting production and deal with them in a systematic, methodical manner.
- Prepare manufacturing documentation required for product manufacture.
- Coordinate projects.
- Identify ways to reduce production costs.
- Work with R&D and other departments to produce cost estimates for new designs.
- Work with regulatory bodies to ensure safety, environmental and design standards are met.
- Serve as a team member in support of design for manufacturability.
- Assist R&D in the transition of new products to production product status.
- Generate and update assembly documentation (travelers/work instructions).
- Process engineering changes (ECNs) Control manufacturing costs by employing creative manufacturing and assembly methods (fixture design).
- Determine and review product cost.
- Provide production floor support.
Qualifications:
- BS in mechanical, industrial, or manufacturing engineering. Strong background in interpretation of Engineering drawings/specifications and manufacturing process planning/evaluation.
- Prior experience in machine shop practices including milling, turning and grinding is a plus.
- Experience with Six Sigma.
- Previous experience with automation is a plus.
- Experience with mechanical design using SolidWorks.
- Minimum of 7 years of related experience – preferably in the medical device industry or other highly regulated industry.
- Excellent written and verbal communication skills. Prior experience in technical writing and procedure development.
- Must have demonstrated ability to work as part of a team.
- Strong analytical and problem solving skills.
- Must be self-motivated.
