What are the responsibilities and job description for the Product Analysis Engineer position at LanceSoft, Inc.?
Job Title: Product Analysis Engineer I
Location: Burlington MA 01803
Duration: 6 Months
Shift: 8:00 AM to 5:00 PM
Job Summary:
Main Purpose Of Role
Main Responsibilities
Qualifications:
Location: Burlington MA 01803
Duration: 6 Months
Shift: 8:00 AM to 5:00 PM
Job Summary:
- This position will support manufacturing processes for medical implant and medical external cable assemblies with primary focus on injection molding and soldering of cables to connectors.
- This position will design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality.
- Job Duties: List the significant/essential duties, tasks or responsibilities which employees in this position are required to perform.
- Support Liquid Silicone Rubber (LSR) injection molding processes on a BOY machine and thermoplastic injection molding processes on Illinois Precision Corporation (IPC) machine Support soldering processes of cables to connectors Design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality Evaluation of production equipment Production support and process validation Interface with vendors for incoming components Troubleshoot manufacturing process and equipment Utilize tools like Gage R&R, Cp, Cpk, and SPC to improve processes Understand manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput.
- Protocol and report writing Generate and modify manufacturing process documentation Work with cross functional teams as required Develop and implement process improvements Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performs other related duties and responsibilities, on occasion, as assigned.
- Equipment: List the type of equipment the incumbent will utilize in this position.
- May, on occasion, work with a variety of production equipment, small hand tools, test equipment, and precision measuring instruments.
- Also uses standard office equipment such as telephone, fax/copier, and a personal computer with standard office software.
- Working Conditions: Describe the work environment characteristics representative of those encountered by an employee performing the essential functions of this job. Work environment varies from well lighted office/cubicle, low to moderate noise level, to a variety of conditions caused by travel requirements such as customer offices, research labs, hospitals, hotels, use of automobiles, commercial travel, weather, etc.
- Physical Demands: Describe the physical demands representative of those that must be met by an employee to successfully perform the essential functions of this job. Activities require a significant amount of sitting in front of a computer monitor, some standing and walking.
- Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment.
- Performs tasks that regularly require good correctable vision and hand/eye coordination. Activities also require significant use of voice and hearing for discussions with other employees.
Main Purpose Of Role
- Perform failure analysis on explanted biomedical implant product. Provide technical expertise to the Product Analysis Laboratory.
- Analyzes failures, develops, and implements investigative protocols to identify root causes, performs circuit
- analysis, performs device and component level failure analysis.
Main Responsibilities
- Perform failure analysis on explanted long-term biomedical implant product.
- Work requires the application of theoretical principals, evaluation, ingenuity, and creative/analytical techniques to identify route cause failure mechanisms.
- Must be able to meet deadlines on multiple assignments and be able to operate in a diverse cross-functional team environment.
- Proactive in finding quality improvements related to Failure Analysis
- May serve as lead and assign work to less experienced personnel and serves as a mentor when assisting less experienced lab staff in solving more complex problems.
- Works cross functionally and collaboratively with Product Development, Engineering, Manufacturing, and ProductSurveillance.
- Aides in definition of test equipment as required to accomplish quality responsibilities.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS),Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies,operating procedures, processes, and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Qualifications:
- Bachelor’s Degree in Engineering is Required
- Electrical or Biomedical Engineering is preferred
- Engineering work experience is preferred
- Knowledge of global regulations for medical device reporting and medical terminology is a positive
- Strong written and oral communication skills are required
- Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing
- tasks and investigations simultaneously
- Multitasks, prioritizes, and meets deadlines in a timely manner
- Strong organizational and follow-up skills, as well as attention to detail
Salary : $40 - $45
