Systems Completion Lead II Job at Airswift Sweden (Midland)

Engineer II, Systems C&S

This is where new knowledge is discovered. Baxter's Research and Development tea...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Mechanical engineering, Electrical Engineering, Electronics Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field
3 to 8 yrs of experience, mainly in Codes and Standards, testing & System engineering function of Electro-Mechanical System Design
Experience in Medical Device development, FDA Regulations and MDR
Exposure to Usability Engineering Process
Experience in QFD, Pugh Matrix, CTQ, DFR, DFX
Strong interpersonal skills with the ability to collaborate with others in a team environment
Understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards
Excellence in Medical Devices safety (IEC 60601-1 and collaterals for medical devices like cardiology, patient monitoring and respiratory therapies), FDA Regulations or other applicable regulatory requirements
Excellence in Medical Device software life cycle processes (IEC 62304), EMI/ EMC requirements, REACH, ROHS and Biocompatibility
Demonstrated experience in accomplishing objectives. Able to deliver on multiple projects simultaneously

Job Responsibility

Identify and define internal and external customer needs, functions, performance, usability and safety requirement for product or solution with thorough knowledge and understanding constraints - Business and Regulatory, C&S assessment early in the development cycle working independently or under the guidance of senior staff
Execute compliance testing as a part of the development team to ensure that the project successfully meets cost, quality and schedule targets throughout the product life cycle
Use tools such as DOORS and excels in the management of requirements and decomposition of system level requirements to modules and their respective compliance requirements
Carry out risk management process in accordance with the EN ISO 14971 throughout product life cycle to ensure compliance and product safety
Excels in the application of principles of Reliability and Robustness in the development of products or solution
Completes detailed, high quality technical documentation to capture and communicate designs
As Lead integrator for the product proactively look out for integration issues during development tests and ensure module / system development is successful
Lead the effort in complying with IEC 60601-1 and collateral standards to obtain product approvals from external safety test labs and notified bodies (DQS, UL, ETL, TUV, LNE, etc.)
Excels in obtaining and maintaining 3rd party Product Certifications, Type approvals and technical files
Actively engage with verification and validation engineers to aid in the development of verification scripts with good test coverage

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Eng II, Systems C&S

This is where new knowledge is discovered. Baxter’s Research and Development tea...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Mechanical engineering, Electrical Engineering, Electronics Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field
3 to 8 yrs of experience, mainly in Codes and Standards, testing & System engineering function of Electro-Mechanical System Design
Experience in Medical Device development, FDA Regulations and MDR
Exposure to Usability Engineering Process
Experience in QFD, Pugh Matrix, CTQ, DFR, DFX
Strong interpersonal skills with the ability to collaborate with others in a team environment
Understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards
Excellence in Medical Devices safety (IEC 60601-1 and collaterals for medical devices like cardiology, patient monitoring and respiratory therapies), FDA Regulations or other applicable regulatory requirements
Excellence in Medical Device software life cycle processes (IEC 62304), EMI/ EMC requirements, REACH, ROHS and Biocompatibility
Demonstrated experience in accomplishing objectives

Job Responsibility

Identify and define internal and external customer needs, functions, performance, usability and safety requirement for product or solution with thorough knowledge and understanding constraints - Business and Regulatory, C&S assessment early in the development cycle working independently or under the guidance of senior staff
Execute compliance testing as a part of the development team to ensure that the project successfully meets cost, quality and schedule targets throughout the product life cycle
Use tools such as DOORS and excels in the management of requirements and decomposition of system level requirements to modules and their respective compliance requirements
Carry out risk management process in accordance with the EN ISO 14971 throughout product life cycle to ensure compliance and product safety
Excels in the application of principles of Reliability and Robustness in the development of products or solution
Completes detailed, high quality technical documentation to capture and communicate designs
As Lead integrator for the product proactively look out for integration issues during development tests and ensure module / system development is successful
Lead the effort in complying with IEC 60601-1 and collateral standards to obtain product approvals from external safety test labs and notified bodies (DQS, UL, ETL, TUV, LNE, etc.)
Excels in obtaining and maintaining 3rd party Product Certifications, Type approvals and technical files
Actively engage with verification and validation engineers to aid in the development of verification scripts with good test coverage

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Quality Systems Specialist II

The Quality Systems Specialist II position is responsible for the support of a c...

Location

United States , Burnsville

Salary:

75000.00 - 110000.00 USD / Year

Imricor Medical Systems

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a related technical field
3-5 years of experience in quality assurance or other quality systems roles in the medical device industry
Previous CAPA and nonconformance experience and demonstrated use of quality tools and methodologies
Detailed knowledge of 21 CFR Part 820, ISO 13485, EU MDR, and other global regulatory requirements
Advanced computer skills, including statistical/data analysis and report writing skills
Strong verbal and written communication skills
Excellent attention to detail
Multitasks prioritize and meet deadlines promptly

Job Responsibility

Develops and maintains quality system procedures to ensure compliance with regulations and industry standards
Participates in internal and external quality audits to ensure compliance with regulations and standards
Participates in, or leads, the completion of CAPA projects, assuring compliance, quality, and timeliness of records
Investigate and resolve quality issues, including conducting root cause analysis and implementing corrective and preventive actions
Leads meetings and communications for CAPA updates, information, and concerns
Monitors and analyzes quality metrics to identify areas for improvement and initiate corrective actions
Provides backup support for engineering change orders and other document change requests
Develops and maintains electronic quality management system processes
Provides cross-functional training and support as needed
Collaborates with cross-functional teams to ensure quality standards are met throughout the product lifecycle

What we offer

Medical
Dental
Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Retirement Benefits

Fulltime

Systems Engineer II

We are looking for a Systems Engineer to be responsible for the coordination and...

Location

United States , Milwaukee

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Bachelor's degree in Electrical, Mechanical, Software, Biomedical Engineering, or related field (or equivalent experience)
3+ years of experience in systems engineering or product development
Proven experience in system development including requirements and risk management, usability engineering, performance and reliability engineering, and cybersecurity considerations
Hands-on experience with product development tools/methodologies (QFD, Pugh Matrix, CTQ, DFR, DFX)
Experience leading or contributing to system architecture and design efforts
Strong understanding of design controls and documentation (DHF ownership, traceability, V&V)
Excellent communication, leadership, and cross-functional collaboration skills
Strong organizational skills and ability to manage multiple priorities
Ability to work independently and drive tasks to completion with minimal supervision
Proficiency in Microsoft Office tools

Job Responsibility

Lead the end-to-end product development lifecycle from user needs definition through product launch
Partner with Engineering Project Management to scope and define projects aligned to program goals
Translate market and customer needs into clear, actionable technical requirements
Own and maintain the Design History File (DHF), ensuring completeness and compliance
Develop system-level specifications and ensure proper decomposition into subsystem requirements
Lead risk management activities in accordance with IEC 14971
Ensure usability requirements are addressed in compliance with IEC 62366
Create and manage Verification and Validation (V&V) plans to support product traceability
Ensure traceability between requirements, design, and verification activities
Lead system architecture development, including interface and subsystem specifications

What we offer

Medical, vision, dental, and life and disability insurance
Company 401(k) plan
Free online training
Access to top jobs
Competitive compensation

Lead Electronic Security Systems & Project Manager

Reporting to the Director of Facility Management & Campus Operations in the Depa...

Location

United States , Denver

Salary:

37.00 - 40.00 USD / Hour

The University Of Denver

Expiration Date

Until further notice

Requirements

High school diploma or equivalent
technical certification or associate degree preferred
Minimum of five years of experience with fire alarm, access control, and security systems in a campus or institutional environment
Demonstrated experience managing multiple system brands and coordinating with fire authorities
NICET II (or higher) Fire Alarm Systems certification or equivalent required
Denver Fire Department Fire Alarm Journeyman License
Previous experience as an installer and/or service technician of low voltage electronic systems (i.e. intrusion alarm systems, card access, fire alarm systems and CCTV)
Must possess and maintain a valid Colorado drivers license and be insurable under University guidelines
or, obtain a valid Colorado's driver's license within the required time frame
Must pass a complete background check to include criminal, motor vehicle report and verification of employment and education

Job Responsibility

Facilitate the maintenance, programming and repair of all campus-wide access control (C-Cure) and alarmed security systems as required
Install, program, test, maintain, and repair multiple brands of fire alarm panels, initiating devices, and notification appliances
Participate in fire and life safety system testing, including annual inspections, load testing, and device replacement
Creates and maintains records of each fire alarm account
Serves as project manager to oversee contracted vendors performing life safety system work to ensure quality and code compliance
Assists in the coordination of installation and/or integration of all new fire alarm systems
Assist in design review and commissioning of new construction or renovation projects affecting life safety systems
Develop and facilitate training for Campus Safety personnel to trouble-shoot fire alarm problems and the operation of new fire alarm systems
Leads one full-time electronic systems technician
Adheres to all Department and University policies, procedures, directives, rules, and regulations

What we offer

medical
dental
retirement
paid time off
tuition benefit
ECO pass

Fulltime

New

Eng II, Electrical

This is where new knowledge is discovered. Baxter’s Research and Development tea...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Electrical/ Electronic engineering with 4-7 yrs. of work experience in design and development, testing of complex electrical/ Electronic components/ subsystems/ products
Experience in electromechanical hardware development, preferably medical devices or other highly regulated products such as military hardware
Ability to generate alternative solutions to problems or processes
Strong interpersonal skills with the ability to work collaboratively with others in a team environment
Excellent background in fundamentals of circuit design and analysis
Experience with industry leading software tools for schematic entry and PCB layout design
Experience with established development tools and processes. Especially PSpice, OrCAD, Mentor's DxDesigner and Expedition
Hands-on experience with analog/digital circuit and embedded systems designs is required
Hands-on experience with embedded platforms, 8-, 16- and 32-bit microcontrollers, Arm Cortex-M series processors
Experience in CAN, SPI, I2C and UART

Job Responsibility

Identifies technical problems, provides innovative, creative solutions
shares technical knowledge with team
Understanding of business, market, industry and competitive knowledge & integrating into technical solutions that can be readily adapted to changes in technology and/or clinical use
Generates alternatives and takes reasonable risks while solving technical problems
Work and collaborate closely with Project Manager & Team leads to define and solve engineering changes/problems to make products that meet all performance and functional criteria within required project schedule, with minimum guidance
Participate in design/change reviews with the Sustaining Team and Engineering Change Board – justify design detail and collaborate with other team members
Completes detailed, high quality technical documentation of product designs through the generation and maintenance of design requirement specifications, engineering prints, material specifications and bills-of-materials
Uses existing engineering tools and best practices to report and track product and process metrics
Challenges project teams and established work processes and proactively finds creative methods to reach desired performance levels
Informs others proactively about developments or issues that affect their work, and their ability to meet commitments

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

New

Quality Lab Associate II - Group Leader

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Marion

Salary:

68000.00 - 93500.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

B.S. degree in Sciences: Biology or Microbiology preferred
Minimum 3 years experience in a Quality Control Laboratory, Environmental Monitoring Lab, or Microbiology Lab
Solid understanding of Environmental Monitoring
Computer literate/knowledge of Microsoft office applications (Word, Excel)
Attention to detail and strong organizational skills
Must have advanced understanding of laboratory instrumentation
Good documentation skills and knowledge of GDPs (Good Documentation Practices)
Exhibits writing and document review proficiency
Able to handle multiple tasks/priorities
Strong knowledge of BLAS, BAxLIMS (or equivalent lab system) and TrackWise

Job Responsibility

Perform Environmental Monitoring tests such as surfaces, viable air, non-viable air, air pressures, etc.
Maintain laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed
Follow laboratory safety procedures to ensure compliance or to make improvements as needed
Monitor operational procedures in technical environments to ensure conformance to standards
Operate lab equipment such as SAS machines, CLIMETs, etc.
Review samples received, logs samples, and enter data into computer database
Responsible for general housekeeping of laboratory and test suites
Sustain a clean and safe work environment applying 6S principles
Perform routine laboratory and safety audits
Serve as mentor to Quality Laboratory Associate (QLA) I and II positions

What we offer

Support for Parents
Continuing Education/Professional Development
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

New

Performance Engineer II, PV & BESS

Bowman has an opportunity for a Performance Engineer II, PV & BESS to join our t...

Location

United States

Salary:

85000.00 - 110000.00 USD / Year

Bowman

Expiration Date

Until further notice

Requirements

Bachelor’s degree in applied mathematics, computational science, electrical engineering, or related field required
Three or more (3+) years of industry experience, preferably in computer science and statistical analysis
Proficient in computer software, such as PVSyst, Excel, PVCase, Helioscope, Homer, System Advisory Model (SAM), Python Script/R
Knowledgeable in capacity testing (ATSM 2838), temperature corrected performance modeling, availability testing, snow and soiling loss models, and general data analytics
Demonstrated work experience in Solar PV industry
Knowledgeable in statistical, large data and uncertainty analysis
Experience with meteorological data sets such as Solar Anywhere and National Solar Radiation Database (NSRBD)
Proficiency in AutoCAD required
Experience in performing shading analysis

Job Responsibility

Develop predictive models to analyze PV system and Energy Storage System (BESS) production and performance using local climate data, system design parameters, and site-specific variables
Receive broad guidance relating to overall key objectives, critical issues, new concepts, and policy matters and general parameters for execution
Receive direction as needed, and especially on highly complex assignments
Independently apply extensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields
Review work produced by staff for quality assurance
Lead and participate in the design and development of production and performance modeling standards
Learn and enhance modeling templates, standards, and best practices
Identify issues on projects and collaborate with clients, coworkers, and others to execute effective solutions
Interact with team members, clients, installation contractors, and others to create efficient and cohesive designs
Report the status of progress on a weekly or daily basis as needed

What we offer

Medical, dental, vision, life, and disability insurance
401(k) retirement savings plan with company match
Paid time off, sick leave, and paid holidays
Tuition reimbursement and professional development support
Discretionary bonuses and other performance-based incentives
Employee Assistance Program (EAP), wellness initiatives, and employee discounts

Fulltime

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Systems Completion Lead II

Job Description

Job Responsibility

Requirements

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