Precision Optics Inc. jobs - 13 jobs

Full-time Description As an entry-level medical device assembler, you will play a vital role in the production process by assembling components of medical devices with precision and care. This position is an excellent opportunity to develop skills in the medical device industry and contribute to the creation of important products that enhance patient care. Principal Responsibilities Follow detailed instructions and blueprints to build or assemble complex optical and mechanical devices to ensure that each device meets strict quality standards. Work with small parts and tools, which requires a steady hand and keen attention to detail. Responsible for conducting quality checks on assembled products, maintaining a clean and organized workspace, and collaborating with team members to meet production goals. Completes appropriate inspection report/production records, as required. Cleans and inspects optical components for use in optical and mechanical assemblies. Perform miscellaneous duties and projects as assigned and required. Requirements Basic understanding of medical device assembly Follows written and verbal instructions Performs repetitive tasks, such as cleaning and organizing workstations Maintains quality standards and safety protocols Familiarity with tools and equipment used in assembly, such as soldering irons, microscopes, or assembly jigs, is beneficial Basic mechanical or electrical skills can also be an asset Soldering experience and correct handling, measuring and mixing of epoxies would be a big plus Attention to Detail: The ability to follow detailed instructions precisely and to carefully examine assembled devices for quality and accuracy is crucial Manual Dexterity: Good hand-eye coordination and fine motor skills are important for working with small components and performing intricate assembly tasks Problem-Solving Skills: An entry-level assembler should be able to identify and troubleshoot basic assembly issues or defects during the manufacturing process Teamwork: The ability to work effectively in a team environment and communicate well with colleagues is important for meeting production goals Willingness to Learn: A desire to learn new skills is essential Basic Computer Skills: Some familiarity with computers Education Requirements High School Diploma or equivalent required. Post-secondary education would be helpful. Supervisory Responsibility No supervisory responsibility. Working Conditions This job operates in manufacturing laboratory environments including ISO class 7 cleanrooms. Physical surroundings This role routinely uses standard office equipment such as computers, phones, filing cabinets. PPE required when in controlled environment rooms. Physical Effort While performing duties of this job, the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear. Travel Limited, local travel may be required.

Primary Responsibility is to carry out the daily activities of Stores, Shipping and Receiving Principle Responsibilities: Routinely receives materials to stores, verifies item identity and count, makes transaction to MRP system, and stocks parts in proper location. Picks parts to fill work orders, noting parts count and lot number on work order, notes material shortages and back fills shortages as available. Dispenses materials on a timely basis to fill replacement needs Maintains accuracy of on-hand inventory balance and performs cycle count on a routine basis Maintains security of Stores and its contents As necessary, receives incoming materials, makes transactions into MRP system, initiates appropriate inspection report and delivers materials appropriately As necessary, in support of existing personnel, prepares product for shipment and fills out shipping documents. Must be familiar with the Company's Quality System All other duties as directed by Manager. Requirements Education: High School or equivalent Supervisory Experience : May have supervisory experience. Experience: Minimum one year work experience in a regulated manufacturing/industrial environment. Understanding of storeroom operations and safeguards desirable. Good organizational skills. Good Communication and interpersonal skills Working knowledge in Microsoft Office. Experience working with a Quality Management System. Experience using MRP (Material Requirement Planning) Software, preferably Acumatica. Working Conditions This job operates in manufacturing environments. Physical surroundings This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. PPE required when in controlled environment rooms. Physical Effort While performing duties of this job, the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear. Travel Limited, infrequent travel may be required. Salary Description $22 - $23 / hour

Full-time Description The Senior Manufacturing Engineer is a key contributor to the design and development of manufacturing processes, tools, and procedures. Provides direct engineering support for New Product Introduction (NPI), development of assembly & test processes, tools, and inspection methods. Identifies and leads and continuous improvement activities and projects. Responsible for manufacturing process verification & validation and employee training effectiveness. Ensures the smooth running of manufacturing processes with the highest possible quality and efficiency. Principal Responsibilities Designs, develops and documents manufacturing systems, processes and tools for new products, product & process changes, to meet targets for quality, efficiency, and reliability. Creates and maintains manufacturing plans, procedures, process FMEAs, flowcharts, workflows, layouts, routings, time standards, and associated tools/equipment, fixtures, and material handling systems. Provides direct manufacturing engineering support for product characterization, and product builds at prototype, verification, validation, and commercial manufacturing stages, to meet ISO 13485 requirements & FDA regulations. Interfaces with design engineers during new product development or product enhancement projects to develop DMR documentation and assure design for manufacturability, assembly & test. Identifies/leads continuous improvement projects using Lean methodologies to improve manufacturing/business systems, processes, and tools to improve quality, eliminate waste, and reduce cost; fosters a Lean culture. Maintains manufacturing master data in ERP systems; initiates/approves engineering change requests/orders. Drives and supports the implementation of effective manufacturing process controls, statistical measurements, and metrics to assure products & processes meet quality and business objectives. Performs capacity and utilization studies, time and motion studies, labor/cycle time analysis, and line balancing. Represents manufacturing in all internal quality processes including MRB & non-conformance handling, complaint reviews, and internal and external quality audits; drives resolution of quality issues using CAPA systems. Functions as the lead technical liaison with suppliers and contract manufacturers; provides technical guidance to suppliers regarding compliance with engineering drawings and other technical requirements/specifications. Partners with quality engineering and suppliers to ensure corrective action or problem resolution to meet quality, cost and delivery targets, and support supplier performance management. Leads large scale projects related to facility moves, re-layouts, Lean training, and Lean transformation projects. Perform miscellaneous duties and projects as assigned and required. Requirements Training, Skills, Knowledge and/or Experience 8+ years of related manufacturing/industrial engineering work experience required, including 3+ years of experience with medical devices in FDA QSR & ISO13485 regulated environment. Experience with manufacturing of complex electro-mechanical products required; some quality engineering experience and exposure to opto-mechanical/electrical product manufacturing preferred. Proven track record of creating FMEAs, performing process verification and validation, developing & validating test methods, and transferring new products into manufacturing. Lean and/or Six Sigma Black Belt certification highly preferred, with demonstrated success in rolling out Lean methods and tools to improve quality and efficiency in manufacturing environments. Microsoft Office 365 Suite & ERP/PLM proficiency required, with working knowledge with SolidWorks, Microsoft Visio, Microsoft Access, Microsoft Project, and electronic documentation systems. Demonstrated experience in data collection and statistical analysis, proficiency with Minitab or other statistical software highly preferred. Demonstrated understanding of mechanical dimensioning and tolerancing, interpretation of component specifications, Quality tools/methodologies, problem solving and root cause analysis, 5S and poka-yoke. Education Requirements Bachelor's degree in manufacturing, industrial engineering, or a related technical field; master's degree preferred. Master's degree preferred. Competencies In-depth understanding of lean manufacturing and supply-chain management methods and tools. Strong attention to detail, with excellent analytical, problem-solving, and project management skills. Strong data collection & analysis, problem solving, presentation and communication skills. Adept at summarizing and presenting complex information to non-technical personnel. Ability to learn and utilize new knowledge quickly and effectively, work independently, without appreciable direction. Supervisory Responsibility None. Working Conditions This job operates in manufacturing and engineering laboratory environments including ISO class 7 cleanrooms. PPE required when in controlled environment rooms or cleanrooms. Physical surroundings This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. Manufacturing & laboratory environments require the use of electrical and mechanical equipment and tools. Physical Effort While performing duties of this job, the employee is occasionally required to stand, walk, sit, use hands to finger, handle, or feel objects, manufacturing tools, equipment, products, and systems; reach with hands and arms; talk and hear. Work Schedule / Travel In-person, Monday to Friday; occasional travel of 10 to 20%. Other Requirements Applicants must have US citizenship or US person status. Salary Description $110,000 - $130,000 a year

Full-time Description Responsible for contribution to the design of products, production fixtures and methods, and testing solutions. Participation in solving technical problems in design, manufacturing, fabrication, inspection, and maintenance. Assists engineers, inspects products, conducts tests, reworks material, and collects data. Principal Responsibilities Act as an engineering resource in transferring new products to manufacturing and sustaining transferred products. Develop and document assembly, test, and alignment methods; prepare drawings and visual aids; read, follow, critique, and edit work instructions. Assemble fragile and sensitive electro-mechanical and optical medical devices. Train manufacturing staff on assembly methods/procedures. Conduct experiments and record data in a laboratory environment; perform data analysis. Collaborate directly with engineers, production operators, quality inspectors and management personnel. Communicate technical issues clearly and effectively to engineering staff. Establish and maintain stability of late-stage development programs and build activity. Maintain adequate inventory of all laboratory supplies (e.g., epoxies, Q-tips, etc.). Understand and comply with the company's quality system; support compliance with FDA QSR, ISO 13485, and other regulatory requirements. Perform miscellaneous duties and projects as assigned and required. Requirements Training, Skills, Knowledge and/or Experience 3 years' experience in a manufacturing, development, or engineering environment with precision devices; background with optics, electronics and/or other small, delicate, or sensitive products. Strong mechanical and general software aptitude. Ability to quickly learn new technologies and tools. General understanding of data collection, data reduction, and statistics. Experience working in FDA QSR and ISO 13485 environments preferred. Experience interfacing with quality, stockroom, production control, purchasing, and engineering personnel. Working knowledge of Microsoft 365 apps suite, basic use of ERP/MRP systems. Education Requirements High School Diploma or GED required. Associate, two-year technical degree, or equivalent level of education preferred. Supervisory Responsibility No supervisory responsibility. Working Conditions This job operates in manufacturing and engineering laboratory environments including ISO class 7 cleanrooms. Physical surroundings This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. PPE required when in controlled environment rooms. Physical Effort While performing duties of this job, the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear. Travel Limited, infrequent travel may be required. Salary Description $22 - $32 / hour

Job DescriptionDescription: Primary Responsibility is to carry out the daily activities of Stores, Shipping and Receiving Principle Responsibilities: Routinely receives materials to stores, verifies item identity and count, makes transaction to MRP system, and stocks parts in proper location. Picks parts to fill work orders, noting parts count and lot number on work order, notes material shortages and back fills shortages as available. Dispenses materials on a timely basis to fill replacement needs Maintains accuracy of on-hand inventory balance and performs cycle count on a routine basis Maintains security of Stores and its contents As necessary, receives incoming materials, makes transactions into MRP system, initiates appropriate inspection report and delivers materials appropriately As necessary, in support of existing personnel, prepares product for shipment and fills out shipping documents. Must be familiar with the Company's Quality System All other duties as directed by Manager. Requirements: Education: High School or equivalent Supervisory Experience : May have supervisory experience. Experience: Minimum one year work experience in a regulated manufacturing/industrial environment. Understanding of storeroom operations and safeguards desirable. Good organizational skills. Good Communication and interpersonal skills Working knowledge in Microsoft Office. Experience working with a Quality Management System. Experience using MRP (Material Requirement Planning) Software, preferably Acumatica. Working Conditions This job operates in manufacturing environments. Physical surroundings This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. PPE required when in controlled environment rooms. Physical Effort While performing duties of this job, the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear. Travel Limited, infrequent travel may be required.

Job DescriptionDescription: Responsible for contribution to the design of products, production fixtures and methods, and testing solutions. Participation in solving technical problems in design, manufacturing, fabrication, inspection, and maintenance. Assists engineers, inspects products, conducts tests, reworks material, and collects data. Principal Responsibilities Act as an engineering resource in transferring new products to manufacturing and sustaining transferred products. Develop and document assembly, test, and alignment methods; prepare drawings and visual aids; read, follow, critique, and edit work instructions. Assemble fragile and sensitive electro-mechanical and optical medical devices. Train manufacturing staff on assembly methods/procedures. Conduct experiments and record data in a laboratory environment; perform data analysis. Collaborate directly with engineers, production operators, quality inspectors and management personnel. Communicate technical issues clearly and effectively to engineering staff. Establish and maintain stability of late-stage development programs and build activity. Maintain adequate inventory of all laboratory supplies (e.g., epoxies, Q-tips, etc.). Understand and comply with the company's quality system; support compliance with FDA QSR, ISO 13485, and other regulatory requirements. Perform miscellaneous duties and projects as assigned and required. Requirements: Training, Skills, Knowledge and/or Experience 3 years' experience in a manufacturing, development, or engineering environment with precision devices; background with optics, electronics and/or other small, delicate, or sensitive products. Strong mechanical and general software aptitude. Ability to quickly learn new technologies and tools. General understanding of data collection, data reduction, and statistics. Experience working in FDA QSR and ISO 13485 environments preferred. Experience interfacing with quality, stockroom, production control, purchasing, and engineering personnel. Working knowledge of Microsoft 365 apps suite, basic use of ERP/MRP systems. Education Requirements High School Diploma or GED required. Associate, two-year technical degree, or equivalent level of education preferred. Supervisory Responsibility No supervisory responsibility. Working Conditions This job operates in manufacturing and engineering laboratory environments including ISO class 7 cleanrooms. Physical surroundings This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. PPE required when in controlled environment rooms. Physical Effort While performing duties of this job, the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear. Travel Limited, infrequent travel may be required.

Job DescriptionDescription: The Senior Manufacturing Engineer is a key contributor to the design and development of manufacturing processes, tools, and procedures. Provides direct engineering support for New Product Introduction (NPI), development of assembly & test processes, tools, and inspection methods. Identifies and leads and continuous improvement activities and projects. Responsible for manufacturing process verification & validation and employee training effectiveness. Ensures the smooth running of manufacturing processes with the highest possible quality and efficiency. Principal Responsibilities Designs, develops and documents manufacturing systems, processes and tools for new products, product & process changes, to meet targets for quality, efficiency, and reliability. Creates and maintains manufacturing plans, procedures, process FMEAs, flowcharts, workflows, layouts, routings, time standards, and associated tools/equipment, fixtures, and material handling systems. Provides direct manufacturing engineering support for product characterization, and product builds at prototype, verification, validation, and commercial manufacturing stages, to meet ISO 13485 requirements & FDA regulations. Interfaces with design engineers during new product development or product enhancement projects to develop DMR documentation and assure design for manufacturability, assembly & test. Identifies/leads continuous improvement projects using Lean methodologies to improve manufacturing/business systems, processes, and tools to improve quality, eliminate waste, and reduce cost; fosters a Lean culture. Maintains manufacturing master data in ERP systems; initiates/approves engineering change requests/orders. Drives and supports the implementation of effective manufacturing process controls, statistical measurements, and metrics to assure products & processes meet quality and business objectives. Performs capacity and utilization studies, time and motion studies, labor/cycle time analysis, and line balancing. Represents manufacturing in all internal quality processes including MRB & non-conformance handling, complaint reviews, and internal and external quality audits; drives resolution of quality issues using CAPA systems. Functions as the lead technical liaison with suppliers and contract manufacturers; provides technical guidance to suppliers regarding compliance with engineering drawings and other technical requirements/specifications. Partners with quality engineering and suppliers to ensure corrective action or problem resolution to meet quality, cost and delivery targets, and support supplier performance management. Leads large scale projects related to facility moves, re-layouts, Lean training, and Lean transformation projects. Perform miscellaneous duties and projects as assigned and required. Requirements: Training, Skills, Knowledge and/or Experience 8+ years of related manufacturing/industrial engineering work experience required, including 3+ years of experience with medical devices in FDA QSR & ISO13485 regulated environment. Experience with manufacturing of complex electro-mechanical products required; some quality engineering experience and exposure to opto-mechanical/electrical product manufacturing preferred. Proven track record of creating FMEAs, performing process verification and validation, developing & validating test methods, and transferring new products into manufacturing. Lean and/or Six Sigma Black Belt certification highly preferred, with demonstrated success in rolling out Lean methods and tools to improve quality and efficiency in manufacturing environments. Microsoft Office 365 Suite & ERP/PLM proficiency required, with working knowledge with SolidWorks, Microsoft Visio, Microsoft Access, Microsoft Project, and electronic documentation systems. Demonstrated experience in data collection and statistical analysis, proficiency with Minitab or other statistical software highly preferred. Demonstrated understanding of mechanical dimensioning and tolerancing, interpretation of component specifications, Quality tools/methodologies, problem solving and root cause analysis, 5S and poka-yoke. Education Requirements Bachelor's degree in manufacturing, industrial engineering, or a related technical field; master's degree preferred. Master's degree preferred. Competencies In-depth understanding of lean manufacturing and supply-chain management methods and tools. Strong attention to detail, with excellent analytical, problem-solving, and project management skills. Strong data collection & analysis, problem solving, presentation and communication skills. Adept at summarizing and presenting complex information to non-technical personnel. Ability to learn and utilize new knowledge quickly and effectively, work independently, without appreciable direction. Supervisory Responsibility None. Working Conditions This job operates in manufacturing and engineering laboratory environments including ISO class 7 cleanrooms. PPE required when in controlled environment rooms or cleanrooms. Physical surroundings This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. Manufacturing & laboratory environments require the use of electrical and mechanical equipment and tools. Physical Effort While performing duties of this job, the employee is occasionally required to stand, walk, sit, use hands to finger, handle, or feel objects, manufacturing tools, equipment, products, and systems; reach with hands and arms; talk and hear. Work Schedule / Travel In-person, Monday to Friday; occasional travel of 10 to 20%. Other Requirements Applicants must have US citizenship or US person status.

Full-time Description As a mid-level medical device assembler, you will leverage your experience and technical skills to assemble and inspect a variety of medical devices, ensuring they meet stringent quality standards and regulatory requirements. This position not only allows you to deepen your expertise in the medical device industry but also plays a crucial part in delivering safe and effective healthcare solutions. Principal Responsibilities Following work instructions and technical documentation, utilizing your experience in assembly techniques, and operating specialized equipment with precision. Responsible for conducting thorough quality control checks, escalating assembly issues, to ensure productivity and product quality. Troubleshoots basic assembly issues Mentor and train entry-level assemblers, fostering a collaborative team environment. Collaborates with engineering and quality assurance teams. Requirements Proficient in various assembly techniques and tools 2-5 years of experience in medical device assembly or a related manufacturing field is required. Familiarity with specific types of medical devices will be advantageous. Advanced Technical Skills: Proficiency in assembly techniques and the use of specialized tools, such as automated equipment, testing devices, or precise measuring instruments, is necessary. Certified soldering to ISO standards and correct handling, measuring and mixing of epoxies is a must. Quality Control Knowledge: Experience with quality assurance processes, inspections, and documentation practices to ensure compliance with industry standards and regulations (such as ISO 13485 or FDA guidelines). Problem-Solving Abilities: Analytical and troubleshooting skills to identify assembly issues would be extremely beneficial. Leadership and Mentoring: Ability to guide and mentor entry-level assemblers; experience leading small teams or training new staff would be beneficial. Attention to Detail: Enhanced attention to detail to ensure that assembled devices meet rigorous standards for safety and efficacy. Effective Communication Skills: Strong verbal and written communication skills for reporting issues, collaborating with team members. Basic Computer Proficiency: Comfortable using computer software for documentation and tracking production. Adaptability: A Willingness to learn new technologies and adapting to new manufacturing practices will be necessary. Education Requirements High School Diploma or equivalent required. A college degree in a relevant field preferred. Equivalent experience may also be accepted. Supervisory Responsibility No supervisory responsibility. Working Conditions This job operates in manufacturing laboratory environments including ISO class 7 cleanrooms. Physical surroundings This role routinely uses standard office equipment such as computers, phones, filing cabinets. PPE required when in controlled environment rooms. Physical Effort While performing duties of this job, the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear. Travel Limited, local travel may be required Other Requirements This position involves access to technology that is subject to U.S. export controls. Any job offer made will be contingent upon the applicant's capacity to serve in compliance with U.S. export controls . Salary Description $20 - $22 / hour

Job DescriptionDescription: As an entry-level medical device assembler, you will play a vital role in the production process by assembling components of medical devices with precision and care. This position is an excellent opportunity to develop skills in the medical device industry and contribute to the creation of important products that enhance patient care. Principal Responsibilities Follow detailed instructions and blueprints to build or assemble complex optical and mechanical devices to ensure that each device meets strict quality standards. Work with small parts and tools, which requires a steady hand and keen attention to detail. Responsible for conducting quality checks on assembled products, maintaining a clean and organized workspace, and collaborating with team members to meet production goals. Completes appropriate inspection report/production records, as required. Cleans and inspects optical components for use in optical and mechanical assemblies. Perform miscellaneous duties and projects as assigned and required. Requirements: Basic understanding of medical device assembly Follows written and verbal instructions Performs repetitive tasks, such as cleaning and organizing workstations Maintains quality standards and safety protocols Familiarity with tools and equipment used in assembly, such as soldering irons, microscopes, or assembly jigs, is beneficial Basic mechanical or electrical skills can also be an asset Soldering experience and correct handling, measuring and mixing of epoxies would be a big plus Attention to Detail: The ability to follow detailed instructions precisely and to carefully examine assembled devices for quality and accuracy is crucial Manual Dexterity: Good hand-eye coordination and fine motor skills are important for working with small components and performing intricate assembly tasks Problem-Solving Skills: An entry-level assembler should be able to identify and troubleshoot basic assembly issues or defects during the manufacturing process Teamwork: The ability to work effectively in a team environment and communicate well with colleagues is important for meeting production goals Willingness to Learn: A desire to learn new skills is essential Basic Computer Skills: Some familiarity with computers Education Requirements High School Diploma or equivalent required. Post-secondary education would be helpful. Supervisory Responsibility No supervisory responsibility. Working Conditions This job operates in manufacturing laboratory environments including ISO class 7 cleanrooms. Physical surroundings This role routinely uses standard office equipment such as computers, phones, filing cabinets. PPE required when in controlled environment rooms. Physical Effort While performing duties of this job, the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear. Travel Limited, local travel may be required

Job DescriptionDescription: As an entry-level medical device assembler, you will play a vital role in the production process by assembling components of medical devices with precision and care. This position is an excellent opportunity to develop skills in the medical device industry and contribute to the creation of important products that enhance patient care. Principal Responsibilities Follow detailed instructions and blueprints to build or assemble complex optical and mechanical devices to ensure that each device meets strict quality standards. Work with small parts and tools, which requires a steady hand and keen attention to detail. Responsible for conducting quality checks on assembled products, maintaining a clean and organized workspace, and collaborating with team members to meet production goals. Completes appropriate inspection report/production records, as required. Cleans and inspects optical components for use in optical and mechanical assemblies. Perform miscellaneous duties and projects as assigned and required. Requirements: Basic understanding of medical device assembly Follows written and verbal instructions Performs repetitive tasks, such as cleaning and organizing workstations Maintains quality standards and safety protocols Familiarity with tools and equipment used in assembly, such as soldering irons, microscopes, or assembly jigs, is beneficial Basic mechanical or electrical skills can also be an asset Soldering experience and correct handling, measuring and mixing of epoxies would be a big plus Attention to Detail: The ability to follow detailed instructions precisely and to carefully examine assembled devices for quality and accuracy is crucial Manual Dexterity: Good hand-eye coordination and fine motor skills are important for working with small components and performing intricate assembly tasks Problem-Solving Skills: An entry-level assembler should be able to identify and troubleshoot basic assembly issues or defects during the manufacturing process Teamwork: The ability to work effectively in a team environment and communicate well with colleagues is important for meeting production goals Willingness to Learn: A desire to learn new skills is essential Basic Computer Skills: Some familiarity with computers Education Requirements High School Diploma or equivalent required. Post-secondary education would be helpful. Supervisory Responsibility No supervisory responsibility. Working Conditions This job operates in manufacturing laboratory environments including ISO class 7 cleanrooms. Physical surroundings This role routinely uses standard office equipment such as computers, phones, filing cabinets. PPE required when in controlled environment rooms. Physical Effort While performing duties of this job, the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear. Travel Limited, local travel may be required.

Job DescriptionDescription: As a senior medical device assembler, you will take on a critical leadership role in the assembly process, utilizing your extensive experience and technical expertise to ensure the production of high-quality medical devices that comply with industry regulations and standards. This position not only emphasizes your advanced assembly skills but also allows you to play a pivotal role in enhancing patient care through the delivery of safe and reliable medical devices. Principal Responsibilities Oversee complex assembly operations, guiding the assembly team through intricate procedures while troubleshooting any issues that arise. Maintain comprehensive documentation to support compliance with regulatory bodies. Mentor and train new technicians, sharing your knowledge and fostering professional development within the team. Lead assembly projects and initiatives. Ensure compliance with regulatory standards (e.g., FDA). Develop and improve assembly procedures and workflows. Provide technical support and guidance to all assembly team members. Requirements: 5-10 years of experience in medical device assembly or a related manufacturing field is required. Supervisory or leadership experience is a plus. Technical Proficiency: Strong skills in using assembly tools and equipment, familiarity with technical drawings, and proficiency in assembly processes. Regulatory Knowledge: Understanding of FDA regulations, ISO standards, and Good Manufacturing Practices (GMP) related to medical devices. Quality Control: Ability to adhere to quality control protocols and maintain meticulous documentation for compliance and traceability. Problem-Solving Skills: Strong analytical skills for troubleshooting assembly issues and implementing solutions effectively. Communication Skills: Good verbal and written communication skills for effective collaboration with team members and documentation of procedures. Attention to Detail: High level of accuracy in following detailed instructions, with an emphasis on maintaining quality standards. Adaptability: A Willingness to learn new technologies and adapting to new manufacturing practices will be necessary. Teamwork: Strong ability to work collaboratively in a team setting and mentor junior assemblers when needed. Education Requirements High School Diploma or equivalent required. A college degree in a relevant field preferred. Equivalent experience may also be accepted. Supervisory Responsibility No supervisory responsibility. Working Conditions This job operates in manufacturing laboratory environments including ISO class 7 cleanrooms. Physical surroundings This role routinely uses standard office equipment such as computers, phones, and filing cabinets. PPE required when in controlled environment rooms. Physical Effort While performing duties of this job, the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear. Travel Limited, local travel may be required. Other Requirements This position involves access to technology that is subject to U.S. export controls. Any job offer made will be contingent upon the applicant's capacity to serve in compliance with U.S. export controls.

Full-time Description As an entry-level medical device assembler, you will play a vital role in the production process by assembling components of medical devices with precision and care. This position is an excellent opportunity to develop skills in the medical device industry and contribute to the creation of important products that enhance patient care. Principal Responsibilities Follow detailed instructions and blueprints to build or assemble complex optical and mechanical devices to ensure that each device meets strict quality standards. Work with small parts and tools, which requires a steady hand and keen attention to detail. Responsible for conducting quality checks on assembled products, maintaining a clean and organized workspace, and collaborating with team members to meet production goals. Completes appropriate inspection report/production records, as required. Cleans and inspects optical components for use in optical and mechanical assemblies. Perform miscellaneous duties and projects as assigned and required. Requirements Basic understanding of medical device assembly Follows written and verbal instructions Performs repetitive tasks, such as cleaning and organizing workstations Maintains quality standards and safety protocols Familiarity with tools and equipment used in assembly, such as soldering irons, microscopes, or assembly jigs, is beneficial Basic mechanical or electrical skills can also be an asset Soldering experience and correct handling, measuring and mixing of epoxies would be a big plus Attention to Detail: The ability to follow detailed instructions precisely and to carefully examine assembled devices for quality and accuracy is crucial Manual Dexterity: Good hand-eye coordination and fine motor skills are important for working with small components and performing intricate assembly tasks Problem-Solving Skills: An entry-level assembler should be able to identify and troubleshoot basic assembly issues or defects during the manufacturing process Teamwork: The ability to work effectively in a team environment and communicate well with colleagues is important for meeting production goals Willingness to Learn: A desire to learn new skills is essential Basic Computer Skills: Some familiarity with computers Education Requirements High School Diploma or equivalent required. Post-secondary education would be helpful. Supervisory Responsibility No supervisory responsibility. Working Conditions This job operates in manufacturing laboratory environments including ISO class 7 cleanrooms. Physical surroundings This role routinely uses standard office equipment such as computers, phones, filing cabinets. PPE required when in controlled environment rooms. Physical Effort While performing duties of this job, the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear. Travel Limited, local travel may be required Salary Description $19 - $20/ hour