Optical Medical Device Manufacturing
Job title: senior manufacturing engineer
job type: full - time
reports to: director of operations
location: windham, maine
are you a talented optical medical device manufacturing engineer ready to develop and execute manufacturing process plans for optics component manufacturing, continuously improve processes and plans using tools and methods such as statistical process control (spc) and design of experiments (doe), and conceptualize, design and execute tooling/process requirements? If so then read on!
- provide mfg. Engineering support of multiple projects
- manage apqp planning process for new programs
- oversee design and development of new products and processes
- conduct fmea, doe, spc analysis
- direct validation activities for new tools, process and equipment
- develop and submit validation packages for customer approval
- map work flows and develop process control plans
- train personnel to transfer new programs to production
**education and experience required**
- b.S. In mechanical engineering, optical engineering, materials science, and optical engineering, physics, chemical engineering or equivalent experience strongly desired.
- 5-8 years’ experience in engineering with experience in a manufacturing environment
- product development experience specializing in medical device and life science industry
- experience in development programs involving class ii & iii medical devices, 3d modeling,
- drafting experience using solidworks
- experience in iso13485 glp/gmp environment
- experience with design tools (solidworks, cad, 6 sigma principles and practices, fmea, statistical analysis, etc.)
- knowledge of design verification/validation activities (sterilization, biocompatibility, packaging, aging, etc.) strongly desired.
- metal stamping or medical device experience required
- minitab statistical software
- apqp process expertise
- engineering studies analysis
- map process control plans
- written work instruction level documents for manufacturing
- ability to work in a team, be proactive, and proven project management skills experience.
This is a growth position. If you are a talented optical manufacturing engineer with at least five years of experience working with lean manufacturing and medical devices, then we look forward to your resume! kindly attach your resume along with your response on zintro.
We offer: competitive salary, paid holidays, paid vacation, medical insurance, life insurance, supplemental insurance including: dental short term and long term disability, accident insurance and hospital confinement indemnity insurance, 401k with employer contribution.
Applicants must be authorized to work in the u.S.+8 Other Responses
Medical Technologist Ii
Job title: medical technologist ii
job location: cambridge, ma
job type & status: full time & employee
**about the job**:
the medical technologist ii is responsible for managing and performing moderate to high complexity testing, ensuring specimen integrity by adhering to laboratory and departmental policies and procedures to include quality control, quality assurance, and safety. Below are illustrations of the type of work; this is not an all-inclusive list.
**essential duties and responsibilities**:
- specimen handling, processing, and preparing reagents;
- communicating issues to laboratory management; reviewing test analyses with management;
- analyzing, reviewing, and reporting test results and quality control results with management;
- entering and releasing results of test results through the lis/lims;
- taking remedial action when indicated;
- reporting and maintaining records of test results;
- compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data;
- troubleshooting test systems and taking appropriate action when indicated;
- adhering to all laboratory safety policies;
- performing instrument calibration as well as routine, scheduled, and unscheduled preventive maintenance; maintaining equipment, temperature charts, and equipment logs;
- storage and disposal of specimens;
- reviewing sops as assigned;
- identifying problems which may adversely affect test performance or reporting of test results and taking appropriate action including notification of laboratory management;
- participating in laboratory qa programs and laboratory ce programs;
- participating in proficiency testing and competency evaluation throughout the year;
- training new employees including laboratory technologists, medical technologists i, and co-op students/interns;
- oversee technical aspects of assigned assays;
- lead and participate in project based work.
**education, qualifications and experience**:
- position requires a minimum of a bachelor’s degree in medical technology or related life science;
- national certification as a medical technologist (ascp);
- clinical laboratory scientist, or fulfillment of the educational, experience and certification requirements of 42 cfr part 493.1461 as most recently posted in the federal register;
- minimum of 5 plus years of experience testing moderate and high complexity assays;
- familiarity of lab info systems;
- experience in immunology, hplc, traditional chemistry, cell-based assays and iea.
Additional details available on request.
This full time job post is not eligible for visa sponsorship and relocation is not available.
Interested applicants must attach their resumes on zintro.+66 Other Responses