Careers

Job Purpose:

Medical Component Specialists is an experienced contract manufacturer of high-quality medical products. We develop products and technologies that save lives. We look for candidates that would be great additions to our team with a desire to do their job well while learning new skills.

This is your opportunity to join a new team with proprietary technology and automation. We develop medical parts that help save lives. This role produces and repairs precision parts using both manual and automated equipment. You will be part of setting up, programming, adjusting and running complex grinding processes on manual and CNC grinding machines. To be successful in this role, you should possess manual dexterity and an eye for detail as well as respect for safety precautions.

Primary Responsibilities (Essential Functions)

• Review samples, drawings or instructions to understand specifications of output

• Plan the sequence of necessary actions for the completion of a job

• Take measurements and mark material for cutting or shaping

• Select appropriate machines (e.g. lathes) and position or load material for a job

• Determine and program size of batches, speed of machine etc.

• Monitor machine while working to adjust the feed, maintain temperature and identify issues

• Check output to ensure consistency with specifications and discard defects

• Perform routine machine maintenance and repair minor damages

• Ability to make fixturing

Level of Skill, Education and Experience

• Experience with Lathe and/or mill set up and programming

• Proven experience as a hands-on machinist (not just an operator)

• Experience in using and/or programming manual, semi-automated or automated tools and machines (lathes, surface grinders etc.)

• Ability to use precision tools (e.g. calipers) to take accurate measurements

• Knowledge of the properties of metal and other material

• Ability to read blueprints, schematics and manuals

• Good at math with analytical abilities

• Physical stamina and strength to lift heavy items (max 60 pounds)

• High school diploma or equivalent; completion of vocational training or an apprenticeship will be an asset

• At least 1 year CNC experience required

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Job Purpose:

Exciting career opportunity is available at Medical Component Specialists, a rapidly growing medical device contract manufacturer, for a Quality Engineer. The purpose of this role is to develop and implement quality plans, programs and procedures using quality control statistics and lean manufacturing concepts. Review, analyze and report on quality discrepancies, perform root cause investigation, disposition product and material, implement corrective actions and execute quality audits. The team works closely with manufacturing, engineering, customers, suppliers and subcontractors to ensure all aspects of the Quality Management System are met.

Primary Responsibilities (Essential Functions)

• Develop and implement company quality policies, initiatives, and procedures of the Quality Management System and ensure compliance with ISO 13485
• Lead or support teams to investigate internal and external manufacturing quality issues to resolve complaints, non-conforming products and CAPA
• Develop validation and qualification protocols and support the execution of manufacturing process/product qualifications & validations projects
• Working knowledge of risk analysis techniques including PFMEA
• Management of Change Control and Change Notifications with suppliers and customers
• Define in-process inspection & incoming inspection requirements
• Responsibility for ensuring production analysis, analysis of customer complaints, analysis of non-conforming product, scrap and quality costs
• Demonstrated ability to run multiple projects and exhibit strong accountability to achieve scheduled milestones and deliverables
• Strong Blue Print reading skills including GD&T
• Verify dimensions of finished work piece for conformance to specifications using optical comparator, micrometers, pin gages, vision inspection system
• Experience with Microsoft Project, Microsoft Office, E2 and other relevant software systems
• Project management experience
• Excellent written and verbal communication skills
• Positive attitude, team player

Level of Skill, Education and Experience

A minimum B.S. in an engineering discipline or associates degree and equivalent experience with at least three (3) years demonstrated successful performance/experience in a Quality Engineering position in Medical Device manufacturing or regulated industry. Ability to work in a hands on, fast paced manufacturing environment while managing multiple projects. ASQ, CQE/CQA Preferred.

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Purpose

Looking for an experienced Quality Inspector, ideally with a background in medical device inspection. Responsible for QC mechanical inspections and the testing of incoming raw materials and finished goods including inspections required in support of validation activities in accordance with ISO 13485-2016.

Primary Responsibilities:

• Interpret blueprints.
• Strong knowledge and application of GD&T
• Collect and analyze quality data to ensure product meets or exceeds customer expectations.
• As quality issues arise, raise awareness with the team and assist in troubleshooting activities.
• Initiate NCRs (non-conformance reports) as needed.
• Experience using measurement hand tools such as: micrometers, vernier calipers, optical comparators required.
• Assist in troubleshooting operational or quality issues as needed.
• Assist in cross-training and mentoring of other technicians.
• A high level of attention to detail, focus, and accuracy.
• Excellent communication skills.
• Must be a team player.

Level of Skill, Education and Experience

High School Diploma and at least 2-3 years medical device manufacturing/quality experience is required. Experience with metrology hand tools and visual measuring equipment, print interpretation, understanding of geometric dimensions and interpreting tolerances is a must. Basic computer skills and knowledge of Word, Excel, Outlook.

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Job Purpose:

Exciting career opportunity is available at Medical Component Specialists, a rapidly growing medical device contract manufacturer, for a Sr. Manufacturing Engineer. The purpose of this role is to provide Engineering support to daily production activities for medical device manufacturing. The position requires an expertise in medical device manufacturing applications including Swiss machining, Flute Grinding, CNC Programming, work holding, tooling and fixture designs.

Primary Responsibilities (Essential Functions)

• A minimum of 7 years experience in Medical Device manufacturing with an expertise in machining technology.
• Must be self-motivated hands-on individual with a strong sense of urgency and passion for the excellence.
• In depth working knowledge of precision machine shop practices; cutting tools, jig and fixture construction, gauging, assembly and testing practices.
• Experience with standard industry materials, Stainless Steels, Nitinol, Cobalt Chrome.
• Proficiency designing tooling, fixturing and manufacturing systems utilizing 3D Modeling software.
• Create machining programs using Esprit or Machine based software.
• Development of robust manufacturing processes for new product as well as continuous improvement of existing product.
• Product/Process Validation and maintenance.
• Demonstrated ability to run multiple projects and exhibit strong accountability to achieve scheduled milestones and deliverables.
• Knowledge in Lean Manufacturing Processes.
• Exceptional mechanical aptitude.
• Familiarity with ISO quality systems
• Understanding of geometric tolerance standards.
• Strong Blue Print reading skills
• Develop, maintain and process changes to manufacturing procedures and specifications used in manufacturing
• Experience with Microsoft Project, Microsoft Office, E2 and other relevant software systems.
• Project management experience.
• Positive attitude, team player.
• Excellent written and verbal communication skills.
• Verify dimensions of finished work piece for conformance to specifications using optical comparator, micrometers, pin gages, vision inspection system.

Level of Skill, Education and Experience

BS degree in Engineering with at least seven (7) years demonstrated successful performance/experience in an applicable Engineering position. Must have experience in hands on engineering positions involving Machining, Grinding and CNC programming. Ideal candidate would have background in Medical Device manufacturing. Project Management experience a plus.

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Purpose:

Medical Component Specialists is an experienced contract manufacturer of high-quality medical products. We develop products and technologies that save lives. We look for candidates that would be great additions to our team with a desire to do their job well while learning new skills.

The Swiss Tech Lead / Supervisor not only will help to run jobs as time permits they will be the point of contact for this department, providing training and technical assistance as needed. They will be responsible for communicating job statuses to leadership, assigning jobs and machines to the swiss team and improving efficiencies. Looking for a skilled machinist that also has the ability to effectively lead others.

Primary Responsibilities:

• Setup and operate Citizen Swiss machines, knowledge on setting tool holders, guide bushing and collet tension required.
• Experience with setup and operation of bar loaders for sliding head/Swiss machines.
• Advanced skill for reading manufacturing prints and understanding of GD&T required.
• Capable of using micrometers and visual measurement tools to measure down to 0.0003” consistently.
• Familiar with inspection work books and checklists for quality control.
• Understand and execute general machining practices such as insert and tool changes, tool offsets, and workmanship checks.
• Capable of general machine maintenance and minor repairs, including coolant changes, chip cleanouts, and filter changes.
• Programming and G-code edit skills not required but are a plus.
• Must maintain a clean and organized work area.
• Experience using a computer with excel a plus.
• Provide leadership and direction to other members of the swiss machine department including assigning machines, scheduling jobs and providing technical support.
• Communicate with leadership on job status, and completions
• Work in process improvement to increase efficiency
• Manage and schedule regular machine maintenance

Level of Skill, Education and Experience

• Experience in tight tolerance machining with Citizen Cincom Swiss style machines.
• Proven experience as a hands-on machinist (not just an operator)
• Experience in using and/or programming manual, semi-automated or automated tools and machines (lathes, surface grinders etc.)
• Ability to use precision tools (e.g. calipers) to take accurate measurements
• Knowledge of the properties of metal and other material
• Ability to read blueprints, schematics and manuals
• Good at math with analytical abilities
• Physical stamina and strength to lift heavy items (max 60 pounds)
• High school diploma or equivalent; completion of vocational training or an apprenticeship will be an asset
• High school or equivalent (Preferred)
• Swiss Machine: 3 years (Preferred) – Supervisory: 2 years
• High school diploma or equivalent; completion of vocational training or an apprenticeship will be an asset
• At least 1 year CNC experience required

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