Medical Device Manufacturing Tech Job at Solomon Page (Eden Prairie)

Instrument Assembly Associate

Performs electro-mechanical assembly of flow cytometers, sub-assemblies and rela...

Location

United States , San Jose

Salary:

21.00 - 24.00 USD / Hour

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

Experience working in a medical device manufacturing organization
3+ years related experience in a high tech, manufacturing environment
Experience with Excel, Visio, Power Point
Knowledge of ISO 9000, cGMP 21 CFR part 820 or FDA
Performs electro-mechanical assembly and sub-assemblies for medical device products
SAP experience preferred
Ability to effectively communicate information and respond to questions both verbally and in writing
Good mechanical aptitude, dexterity and hand/eye coordination
Must be able to reach, bend and lift 35 lbs on a daily basis
Experienced PC or MAC user, familiar with: Word, Excel, Windows and/or MAC OS

Job Responsibility

Performs electro-mechanical assembly of flow cytometers, sub-assemblies and related medical device products
Follows established methods and procedures in performing, assembly of optical, mechanical, fluidic and electronic components and assemblies
Employs high standards of workmanship to ensure high quality products are produced on schedule
Performs instrument assembly by following released procedures
Must be able to read and understand: assembly instructions, work orders, Bills of Materials, Standard Operation Procedures, and all other documentation used to control our products and processes
Confers with engineers, technicians, production personnel, and others regarding assembly procedures
Must have the ability to create and maintain productive working relationships within the work team and with other functions
Collaborates with peers to achieve shared departmental goals
Keep work area clean organized and safe
Fill out time sheets and all other required paperwork accurately and on time

Fulltime

Instrument Test Technician

Conducts production testing of assembled flow cytometers and related medical dev...

Location

United States , San Jose

Salary:

26.00 - 30.00 USD / Hour

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

3+ years related experience in a high tech, manufacturing environment
Experience working in a medical device manufacturing organization
Experience testing and troubleshooting: laser based optical systems, fluidic systems, digital and analog circuitry
Ability to effectively communicate information and respond to questions both verbally and in writing
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
Good mechanical aptitude, dexterity and hand/eye coordination. Must be able to reach, bend and lift 35 lbs on a daily basis
Experienced in the use of: DVM’s, Oscilloscope and general test equipment
Experienced PC or MAC user, familiar with: Word, Excel, Windows and/or MAC OS
Must be willing to be trained in other areas of production where the skill level requirements may be lower

Job Responsibility

Performs instrument optimization functions after final assembly: laser alignment, pressure adjustments, electrical adjustments, etc.
Performs final production testing and inspection to ensure products meet performance specifications and standards
Analyzes test results on defective units to determine root cause of failure
Replaces or repairs defective components or assemblies, processes appropriate paperwork, may return unit to assembly for repair
Compares test results with specifications and records test data and plots test results. Generates required documentation to complete the Device History Record (DHR)
Analyzes test results on defective units to determine root cause of failure. Frequently requires engineering support to resolve complex and unique problems
Must be able to read and understand: detailed test instructions, assembly instructions, work orders, test results, Bills of Materials, Standard Operation Procedures, and all other documentation used to control our products and processes
Confers with engineers, technicians, production personnel, and others regarding testing procedures and results and to resolve problems. Determines, develops and documents troubleshooting techniques
Expected to provide feedback on production and test methods, product design issues, continuously strives to improve product quality and operational efficiency
Will provide support to project teams whose objectives may be: quality improvement, cost reduction, cycle time reduction, reliability improvement, increase operational efficiency, or new product introduction

Fulltime

Mechanical Engineering Tech

This role will master the Production Technology and Maintenance Techniques being...

Location

United States , Canaan

Salary:

Not provided

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

10 years of Technical or Manufacturing experience required
2 years medical device manufacturing experience preferred
3 years people leading experience preferred
5 years’ experience with high-speed automated assembly and packaging equipment required
Some PLC experience preferred but not essential
High School Diploma/GED: Required
Associates Degree: Required
BA/BS Degree - Preferred – Industrial or Mechanical Engineering preferred
Effective Oral/written Communication - Proficient
Ability to work as part of a team / Teambuilding - Advanced

Job Responsibility

Loss (Breakdown, Waste, Speed) Investigation and Resolution
Development of Maintenance standards
Implementation of basic maintenance processes for the designated product lines
Building maintenance skills for the operators
Execution of maintenance activities in the line (planned/ unplanned when available)
Ensures compliance with BD quality systems, policies, procedures, and best practices, and all local, state, federal and BD safety regulations, policies, and procedures
Regular, punctual attendance is an essential job function
Willing and able to uphold BD Values
Attending Tier 1 and Production Analysis Board (PAB) meetings providing engineering status of line and agree resource deployment and timings to close losses
Resolve repeat loss issues using systematic problem-solving techniques to determine root cause

Fulltime

Biomed Tech I

Troubleshoots, maintains, and repairs (primarily) non-imaging diagnostic and the...

Location

United States , Chicago

Salary:

33.05 - 49.60 USD / Hour

Advocate Aurora Health

Expiration Date

Until further notice

Requirements

High School Diploma or GED
A valid driver’s license issued by the Division of Motor Vehicles
Two years of experience in preventative maintenance and troubleshooting of biomedical equipment
Basic proficiency in the use of Microsoft Office or similar products (primarily Word and Excel)
Use of personal vehicle for travel to various sites is required/expected
Walks, stands, sits, lifts, bends, and reaches above shoulders throughout the shift
Ability to lift up to 25 lbs. from floor to waist and up to 30 lbs. overhead
and carry up to 40 lbs. at waist height for up to ten feet. Also push with 50 lbs. of force and pull with 40 lbs. of force
Environment can include exposure to dust/dirt, fumes, odors, blood and body fluids
as well as mechanical, electrical, and chemical hazards. As a result, protective clothing must be worn as necessary

Job Responsibility

Troubleshoots, maintains, and repairs (primarily) non-imaging diagnostic and therapeutic medical devices using standard electronic test equipment
Installs, calibrates, and tests new medical electronic devices and systems
Escalates situations or questions beyond their scope of knowledge or responsibility to appropriate staff/vendor resources
Completes assigned tasks on medical electronic devices as per manufacturers' guidelines, relevant codes, standards, and company policies. This includes planned and corrective maintenance, cyber-patching, incoming inspections, recalls, and work related to equipment disposition
Provides operational and technical advice on equipment to medical and clinical staff when needed
Interacts with clinical staff on a regular basis to ensure needs are being met
Acts as a technical resource and mentor for entry level Biomedical technicians and Biomedical students (interns)
Documents and maintains accurate records of all inspections, repairs, adjustments, etc., performed on all equipment, for any work performed by self or a vendor
Interacts with manufacturers’ representatives to obtain the necessary technical product service information
Requests and/or orders necessary repair services and spare parts according to established procedures and contract relationships

What we offer

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program
Premium pay such as shift, on call, and more based on a teammate's job
Incentive pay for select positions
Opportunity for annual increases based on performance

Fulltime

Biomed Tech II

Troubleshoots, maintains, and repairs (primarily) non-imaging diagnostic and the...

Location

United States , Chicago

Salary:

33.05 - 49.60 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

High School Diploma or GED
A valid driver’s license issued by the Division of Motor Vehicles
Two years of experience in preventative maintenance and troubleshooting of biomedical equipment
Basic proficiency in the use of Microsoft Office or similar products (primarily Word and Excel)
Use of personal vehicle for travel to various sites is required/expected
Walks, stands, sits, lifts, bends, and reaches above shoulders throughout the shift
Ability to lift up to 25 lbs. from floor to waist and up to 30 lbs. overhead
and carry up to 40 lbs. at waist height for up to ten feet. Also push with 50 lbs. of force and pull with 40 lbs. of force
Environment can include exposure to dust/dirt, fumes, odors, blood and body fluids
as well as mechanical, electrical, and chemical hazards. As a result, protective clothing must be worn as necessary

Job Responsibility

Troubleshoots, maintains, and repairs (primarily) non-imaging diagnostic and therapeutic medical devices using standard electronic test equipment
Installs, calibrates, and tests new medical electronic devices and systems
Escalates situations or questions beyond their scope of knowledge or responsibility to appropriate staff/vendor resources
Completes assigned tasks on medical electronic devices as per manufacturers' guidelines, relevant codes, standards, and company policies. This includes planned and corrective maintenance, cyber-patching, incoming inspections, recalls, and work related to equipment disposition
Provides operational and technical advice on equipment to medical and clinical staff when needed
Interacts with clinical staff on a regular basis to ensure needs are being met
Acts as a technical resource and mentor for entry level Biomedical technicians and Biomedical students (interns)
Documents and maintains accurate records of all inspections, repairs, adjustments, etc., performed on all equipment, for any work performed by self or a vendor
Interacts with manufacturers’ representatives to obtain the necessary technical product service information
Requests and/or orders necessary repair services and spare parts according to established procedures and contract relationships

What we offer

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program
Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training
Premium pay such as shift, on call, and more based on a teammate's job
Incentive pay for select positions
Opportunity for annual increases based on performance.

Fulltime

Manufacturing Tech III Lead

The Manufacturing Technician III/IV leads others in a variety of complex tasks u...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

2 – 4 years in the pharmaceutical or medical device industry finished dose form preferred
Strong knowledge of aseptic techniques and fill finish experience required
Experience in reviewing and creating controlled documents
Requires a high school diploma
Possesses the skill and aptitude to weigh and measure raw materials and operate basic Benchtop instruments
Strong ability to plan and prioritize complex activities to meet goals and objectives
Strong analytical skills to identify risks and prepare balanced decisions
Excellent organizational, verbal and written communication skills
Detail oriented with strong mechanical aptitude
Positive attitude and strong interpersonal skills to resolve and de-escalate issues.

Job Responsibility

Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines. Is proactive in identifying safety risks and alerts management to take corrective action.
Leads team to successfully and completely accomplish daily tasks
Maintains weekly/daily schedule up to date and provides direction to team
Accountable for completing daily tasks and reporting and escalating issues to management
Works with management to provide a positive culture within operations
Mentors less experienced staff in the performance of aseptic techniques
Prepares solutions, aseptic filling and labeling of vials under sterile and non-sterile conditions, routine solution and filtration, vial and component preparation and sterilization
Assembles, disassembles and operates aseptic filling equipment and lyophilizer equipment in classified cleanroom and controlled non classified environments. Operates vial capper, unloads product from lyophilizers and liquid fill line.
Prepares equipment and components for sterilization and Lyophilization
Operates processing equipment including autoclaves, ovens, vial washers, and depyrogenation, centrifuges, mills equipment.

Fulltime

Mechanical Engineering Tech

Mechanical Engineering Tech position for a Medical Devices Company in Zelienople...

Location

United States , Zelienople, PA

Salary:

20.00 - 24.00 USD / Hour

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

2-year technical degree OR relevant experience
Excellent communication (verbal & written) and interpersonal skills
Ability to read and understand mechanical drawings and electrical schematics
Detail oriented with high level of problem solving and analytical skills
Experience with troubleshooting electromechanical systems
Computer skills: MS Office experience (e.g., Word, Excel, PowerPoint)
Experience in a manufacturing environment in a regulated industry (medical device preferred)
Experience with drafting/CAD/3D modeling a plus
Fixture design experience
Position requires good logic and reasoning ability

Job Responsibility

Writing test protocols, running tests, collecting/sorting/analyzing data, and writing final reports
Assist in the development of Manufacturing Processes, procedures, documentation, and fixtures
Creating rework instructions
Production line issue resolution
Perform process and product validation testing
Assist Engineering in determining new equipment requirements and needs, and incorporate the equipment into the Dymax Calibration and PM systems
Generate CR packets, gather/generate documentation, coordinate/communicate with approval panel

Fulltime

Biomed Equipment Tech II

Location

United States , Kenosha

Salary:

33.05 - 49.60 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

High School Diploma or GED
A valid driver’s license issued by the Division of Motor Vehicles
Two years of experience in preventative maintenance and troubleshooting of biomedical equipment
Basic proficiency in the use of Microsoft Office or similar products (primarily Word and Excel)
Use of personal vehicle for travel to various sites is required/expected
Walks, stands, sits, lifts, bends, and reaches above shoulders throughout the shift
Ability to lift up to 25 lbs. from floor to waist and up to 30 lbs. overhead
and carry up to 40 lbs. at waist height for up to ten feet
Also push with 50 lbs. of force and pull with 40 lbs. of force
Environment can include exposure to dust/dirt, fumes, odors, blood and body fluids

Job Responsibility

Troubleshoots, maintains, and repairs (primarily) non-imaging diagnostic and therapeutic medical devices using standard electronic test equipment
Installs, calibrates, and tests new medical electronic devices and systems
Escalates situations or questions beyond their scope of knowledge or responsibility to appropriate staff/vendor resources
Completes assigned tasks on medical electronic devices as per manufacturers' guidelines, relevant codes, standards, and company policies
This includes planned and corrective maintenance, cyber-patching, incoming inspections, recalls, and work related to equipment disposition
Provides operational and technical advice on equipment to medical and clinical staff when needed
Interacts with clinical staff on a regular basis to ensure needs are being met
Acts as a technical resource and mentor for entry level Biomedical technicians and Biomedical students (interns)
Documents and maintains accurate records of all inspections, repairs, adjustments, etc., performed on all equipment, for any work performed by self or a vendor
Interacts with manufacturers’ representatives to obtain the necessary technical product service information

What we offer

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program

Fulltime

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Medical Device Manufacturing Tech

Job Description

Job Responsibility

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