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Development Resource Group

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Category : Project Leader
Job Type : Permanent
Id : 7716
Region : Twin Cities

Seeking a Senior Project Engineer to lead project team on all technical belongings within field of specialization: manages the technical design of complete plants and approves deliverables of designs: may work on more complex projects whereas the Project Manager will have ordering authority.

 

JOB DUTIES:

  • Be the technical expert and support the team in all project related questions.
  • Approves deliverable for design.
  • Leads preparation of documentation for the installation processes and prepares work packages for other locations if needed.
  • Participates or leads internal and external project reviews or project meetings and organizes and participates in design reviews.
  • Prepares all necessary project execution specifications/documentation for purchase orders and ensures timely submission of purchase orders.
  • Resolves issues and answers questions that may occur during the design, manufacturing, installation and/or commissioning phase of projects; may escalate complex questions and issues to leadership personnel for resolution or guidance.
  • Ensures internal prevention and detection controls are in place that addresses potential business risks of inefficiency, ineffectiveness, fraud, abuse or mismanagement with respect to design and installation.
  • Tracks project schedules to ensure tasks are completed on time and in totality.
  • Manages assigned budget, including cost and quality of subcontracted design services.
  • May implement new engineering tools, processes and guidelines as needed per project or per customer specifications.
  • Provides technical support for claims and deviation management as needed; uses CAQ system to track deviations
  • Domestic and international travel 10% time

 

JOB QUALIFICATIONS:

  • Bachelor's degree from an accredited institution in mechanical, electrical or automation engineering or related field with 5 years of experience in a lead project engineering role; or a combination of education and experience.
  • Excellent skills/knowledge of 3rd party engineering tools (e.g. AutoCAD, E-Plan, Ruplan, etc.) and SAP
  • Proven project management and leadership experience
  • Assertiveness, conflict-resolution ability as well as decision-making skills
  • Excellent cooperation and communication skills
  • Good analytical and problem solving skills
  • MS Office skills: Excel, Word, PowerPoint, Outlook & Project
  • Experience in the food industry and / or with capital equipment preferred


Posted: August 20, 2019, 8:21 am
Category : Electrical Engineer
Job Type : Contract
Id : 7714
Region : Twin Cities

Seeking a Principal Level Electrical Engineer to join a R&D team to design and develop new and modifications to medical device Systems. The Senior Electrical Engineer will also be responsible for designing automated test systems or subsystems for testing the medical device systems.

Areas of responsibilities will include electrical system design, design requirements, test requirements and test procedures, PC-based simulation and data acquisition. Candidates must be able to translate design inputs into electrical options and concepts, write detailed electrical specifications, generate and review design documentation, test specifications and test reports in compliance with design control procedures used within the medical device industry. Candidates must also be willing to work in a fast paced, multi-tasking, team environment.

POSITION RESPONSIBILITIES:

  • The candidate must have the ability to work well with a variety of individuals ranging from the various engineering disciplines (mechanical, electrical, and software) to marketing, clinical, reliability, regulatory and operations.
  • Bring clarity and focus to the early stages of hardware development; ensuring design inputs are translated into hardware/system options. It requires knowledge regarding the integration of features into the early stages of a project when many aspects of the feature set are not yet well defined
  • Review the designs of other engineers and accept input on designs you are responsible for.
  • Learn how the system works so that design choices at the board/module level are in line with the product and system levels.
  • Take input from many sources, analyze existing designs, interpret requirements, apply simulation as appropriate, and drive board and module level design, layout, and test activities.
  • Develop thorough test plans, execute test plans, and analyze data against requirements and design expectations to determine acceptability of the design.
  • Capture how the design works, key characteristics, design decisions and design tradeoffs in documentation to enable efficient long-term support.
  • Support Manufacturing in troubleshooting operations involving medical devices through assembly and test
  • Evaluate and select components, generate component specifications, as well as functional and test specifications
  • Provide technical assistance to other functional departments such as Quality, Reliability, and Manufacturing
  • Work independently, in consultation with Engineering Management
  • Ability to manage and provide day-to-day direction to Electrical Engineers and Technicians

BASIC QUALIFICATIONS/EDUCATION/EXPERIENCE:

  • BS Electrical Engineering
  • Minimum 7+ years experience in circuit design with competence in reading and interpreting existing system specifications, hardware description language codes and schematics.
  • Strong experience in technical specification and report writing
  • Must be able to review the work of other engineers
  • Must be able to work with minimal supervision
  • Mastery of basic laboratory instruments and tools (e.g. DMM and oscilloscope)
  • Ability to work in a team environment; strong collaboration skills
  • Effective verbal and written communication

DESIRED/PREFERRED QUALIFICATIONS:

  • MS Electrical Engineering
  • 5 or more years in one or more of the following: RF ablation generator design, medical device design, embedded microcontroller/microprocessor system design
  • Specific knowledge of Domestic and International standards for Ablation Generators
  • Knowledge of engineering and manufacturing test equipment design and LabView
  • Knowledge of the application of DSPs
  • Experience working with vendors and contract manufacturers for PCB fabrication and assembly
  • Experience writing embedded firmware in assembly and/or C/C++ is a plus
  • Experience with SolidWorks is a plus
  • Mastery of advanced laboratory instruments and tools (e.g. serial data analyzer, logic analyzer, spectrum analyzer, and network analyzer)
  • Experience using and competence in the following are a plus: Writing in hardware description languages such as Verilog or VHDL, Using SPICE, Using Keysight Advanced Design System


Posted: August 19, 2019, 7:18 am
Category : Controls Engineer
Job Type : Permanent
Id : 7711
Region : Twin Cities

Seeking a Principal Automation Engineer to provide concept development, specification (URS authoring), and quoting of automation in support of new opportunities at the Global Innovation and Development (GID) Center or the US manufacturing facilities.

 

Position Responsibilities:

  • Partner with the US supply chain organization to manage the US automation Approved Vendor List (AVL), including performing competency assessments for sources on the AVL to match vendors with suitable opportunities.
  • Serve as the design for assembly / automation Subject Matter Expert for GID development programs
  • Provide project-based technical assistance, as needed, serving as a project team member.
  • Lead specification (URS authoring), sourcing, project management, and/or acceptance (FAT/SAT) of automation projects to support US manufacturing facilities or GID.
  • Work with manufacturing facility engineering & management to identify opportunities for automation and robotics to reduce cost and improve quality, with a focus on flexible automation that can be used across multiple customer programs.
  • Demonstrated flexibility to manage multiple projects and interface with teams at multiple facilities, including temporary assignments at facilities other than the assigned home base for this position.
  • Lead company-wide Automation Council, focused on component standardization, education and exploration of new technologies, and development of automation best practices.
  • Actively participate in continual improvement, corrective action and customer satisfaction.

 

Required Qualifications:

  • Bachelor degree in mechanical engineering, electrical engineering, manufacturing engineering, industrial technology
  • Minimum five (5) years proven experience in automated machine design or assembly
  • Experience with SolidWorks or other mechanical CAD system

 

Posted: August 16, 2019, 9:08 am
Category : Packaging Engineer
Job Type : Permanent
Id : 7712
Region : Twin Cities

Seeking a Packaging and Sterilization Engineer to direct medical packaging programs through development. This position is a resource to medical production facilities to support plant efforts.

 

Essential Functions:

  • Partner with management on setting goals for business implementation and operational effectiveness.
  • Interpret and negotiate packaging, labeling and sterilization requirements to meet customer needs.
  • Act as a packaging resource to partner with Sales, Cost Estimators, Purchasing and Business Development on quoting and sourcing programs with packaging materials and /or services and trade show support.
  • Set top-level project implementation deliverables and dates and manage the execution.
  • Identify software, hardware and equipment needs for packaging and labeling operation.
  • Develop manufacturing line layout plans and determine the space needed for device packaging and labeling.
  • Identify and monitor the supporting resources required for various stages of business implementation, on-going support of the packaging operations, and drive task-level management.
  • Monitor and justify packaging resource requirements.
  • Develop and manage project schedule(s) required to implement packaging components and equipment.
  • Partner with Project Engineers and Program Managers to successfully transition programs from development to production.
  • Coordinate the transfer of contracted packaging/assembly jobs to facilities.
  • Remain up-to-date on the latest trends and technologies in the packaging industry.
  • Instill a mindset that will proactively cause those involved in the business to put all GMP regulations at the forefront of their day-to-day activities.
  • Build partnerships with suppliers and packaging contractors.
  • Support AQP Process Road Map and checklist for assembly/packaging and sterilization programs.
  • Partner with Regulatory/Validation personnel related to Sterilization Management.
  • Extended travel to other facilities may be required to support business needs.
  • Provide backup to the Project Engineering team as required based on project load.
  • Coordinate, direct and lead engineering efforts to ensure optimum engineering of projects/programs to meet customer and manufacturing requirements.
  • Maintain cost control and profitability through interaction with the accounting group, sales and our customers.
  • Facilitate communication between customer, sales, engineering functions, outside vendors, manufacturing and multi-facility groups.

 

Required Qualifications :

  • Bachelor's degree in Packaging Engineering or closely related field
  • 2 + years of product packaging experience preferred
  • Familiar with current regulatory trends and packaging / sterilization requirements preferred
  • Experience in medical product sterilization preferred

 

Skills and Abilities:

  • Excellent written, verbal and presentation communication skills
  • Ability to coordinate multiple projects at one time
  • Ability to work with internal and external customers in a productive and team approach


Posted: August 16, 2019, 9:07 am
Category : Software Engineer
Job Type : Contract
Id : 7707
Region : Twin Cities

Seeking a Software Engineer to join a dynamic and motivated team developing medical products that set the bar for clinical excellence and efficient workflow. As a member of the software development team you will help take these products to the next level and reduce cost, improve quality, increase access.

Essential Responsibilities:

  • Have familiarity with all aspects of Software Development Life Cycle and methodologies
  • Develop and maintain documentation to identify design, requirements and solutions
  • Write well-designed, testable code
  • Integrate software components into functional software system
  • Troubleshoot, debug and upgrade existing systems
  • Support process improvements which guide the development, sustaining & support activities
  • Drive world-class quality in the development and support of products
  • Communicate effectively both within immediate team and also across the program and business leadership team
  • Leveraging DFR for software and Agile and Lean software development methodologies to drive reliability and predictability throughout the product development life cycle

Qualifications/Requirements:

  • Bachelor’s Degree in Computer Science or in “STEM” Majors (Science, Technology, Engineering and Math)
  • 4+ years C++ or C#.net in Microsoft Windows development
  • 4+ years of Agile software development
  • Object Oriented Design Experience Desired Characteristics Technology/Process
  • Master’s Degree in Engineering or Computer Science
  • Experience in software development in the medical field
  • Software development tool experience such as Perforce, Jira, Jenkins Leadership
  • Ability to takes ownership of small and medium sized tasks and deliver while mentoring and helping team members
  • Ensures understanding of issues and presents clear rationale. Able to speak to mutual needs and win-win solutions. Uses two-way communication to influence outcomes and ongoing results


Posted: August 12, 2019, 8:06 am
Category : Quality Engineering
Job Type : Contract
Id : 7706
Region : Twin Cities

Seeking a Principal Supplier Quality Engineer to qualify suppliers according to company standards and administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.

Duties:

  • Ensures that suppliers deliver quality parts, materials, and services.
  • Develops and monitors products from acquisition through the development and manufacturing cycle and communicates and resolves supplier related problems as they occur.
  • Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
  • Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
  • Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels.

Requirements:

  • Requires a University Engineering Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
  • May have broad knowledge of project management.


Posted: August 12, 2019, 6:35 am
Category : Systems Engineer
Job Type : Contract
Id : 7704
Region : Twin Cities

Seeking a System Integration Engineer to work on a Scrum team integrating both software and hardware systems for our Medical Devices. This Engineer will work across teams and sites to identify, diagnose, and find solutions to system level technical problems. This role requires a high degree of initiate to resolve issues.

Essential Responsibilities:

  • Work independently and contribute to the immediate team and to other teams across business.
  • Consistently work on complex systems requiring independent action
  • Support process improvements which guide the development, sustaining & support activities
  • Work cross functionally with other business departments to align activities and deliverables
  • Engage subject matter experts in successful transfer of domain knowledge
  • Have familiarity with all aspects of Software Development Life Cycle and methodologies
  • Proactively share information across the team, to the right audience with the appropriate level of detail and timelines
  • Takes ownership of small and medium sized tasks and deliver while helping team members

Qualifications/Requirements:

  • Bachelor’s Degree
  • 2+ years’ experience in SW development Environment
  • Passion for technology and willingness to learn Desired Characteristics
  • Bachelor’s Degree in Computer Science or in “STEM” Majors (Science, Technology, Engineering and Math)
  • 2+ years programming experience
  • 2+ years of Agile software development
  • Experience in software development in the medical field
  • C++, Linux, Jira, Windchill, Jenkins Personal Attributes
  • Strong oral and written communication skills


Posted: August 9, 2019, 1:26 pm
Category : Systems Engineer
Job Type : Contract
Id : 7703
Region : Twin Cities

Seeking a Systems Engineer who would support development and deployment of test or process control solutions using Automated Equipment.  This Engineer would be responsible for requirements development and testing of software and the hardware portion of the equipment solution.  Additional aspects of the equipment solution development include software/hardware test and troubleshooting while interfacing to the equipment, software validation testing, software validation documentation, and support of application releases.  The Candidate would need to understand software languages and environments including PLC Ladder Logic, LabVIEW, and/or C# in use of manufacturing test and process control equipment.  This position alsotroubleshoots software and hardware problems using root cause analysis and provides technical solutions for equipment-related problems.

 

POSITION RESPONSIBILITIES:

  • Validation of software applications for Automated Equipment to manufacture or test electronic components which utilize software languages and environments preferably in PLC Ladder Logic, LabVIEW or C#.
  • Troubleshooting hardware and software during verification and validation activities all in support of equipment solution release for production testing of electronic components
  • Deployment and qualification and of equipment. Ensures appropriate documentation is maintained and completed for all technology programs transferred to product line specific areas
  • Following software application development procedures and demonstrate compliance through technical documentation generation
  • Active and key participant in the evaluation and strategic planning for new: technology, products and materials and their impact on the business. Performs research and evaluates new ideas & technologies
  • Work is performed with minimal direction
  • All activities must be performed in compliance with the Quality System.
  • Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations
  • Travel requirement: less than 10%

 

POSITION REQUIREMENTS:

  • Bachelors in Electrical Engineering, Controls Engineering, Systems Engineering or related Engineering/Technical discipline
  • 5+ years of experience in Engineering Design and Development with Bachelors
  • 3+ years of experience in Engineering Design and Development with an Advanced degree
  • Familiar with PLC Ladder Logic, LabVIEW, or C# in equipment development
  • 3+ years of experience working in a medical or other regulated industry
  • Strong communication, manufacturing process, product industrialization and leadership skills
  • Solid design, troubleshooting and presentation skills


Posted: August 2, 2019, 7:19 am
Category : Software Engineer
Job Type : Contract
Id : 7702
Region : Twin Cities

As a Sr. Software Engineer, you will be working with motivated, diverse, and knowledgeable development teams to deliver world-class products. You will be responsible for designing, implementing, documenting and testing software for the next generation of Patient Care Software products, both mobile and cloud based. This role requires the ability to work as part of a team to realize complex, innovative, high reliability systems that improve the quality of life of people around the world.

A Day in the Life:

  • Collaborate with the SCRUM teams to provide high quality mobile apps in a fast-paced environment.
  • Create and document all aspects of the software engineering processes for products under development, incorporating the highest quality standards, cost effectiveness, and measurable efficiency.
  • Implementation, execution and verification of unit tests and integration tests.
  • Participate in project planning, estimating, tracking and reporting activities and work with other team members to collaborate on techniques, processes, and designs in an Agile environment.
  • Must work independently or as part of a small team designing and integrating individual portions of a system and participate in software process improvement activities, assuring that all deliverables conform to Company and regulatory standards and audit.

Minimum Qualifications:

  • Bachelor’s degree in Software Engineering, Computer Science or equivalent with 8 to 10 years of designing and developing advanced applications for the Android platform

Desired Qualifications:

  • Experience with Java, Spring (web, JPA), MySQL, Angular, AWS, Kotlin, Docker
  • Experience with Android Jetpack components including: Lifecycle components, Work Manager, Live Data, Room
  • Good understanding of Continuous Integration environments (Jenkins, Bamboo, ElectricCloud)
  • Experience with layered architecture, MVC, Design Patterns
  • Experience with configuration management tools and best practices (GIT, SVN, etc.).
  • Familiarity using test automation tools
  • Excellent problem solving and analytical skills
  • Clarity and precision in verbal and written communication


Posted: August 2, 2019, 7:09 am
Category : Project Leader
Job Type : Permanent
Id : 7695
Region : Twin Cities

Seeking an Installation Site Supervisor to interface with customer and manages subcontractors to efficiently complete projects on time and to company standards.

Position Responsibilities:

  • Keeps projects on schedule and within budget.
  • Is involved in planning and developing the scope of work and schedules for an installation.
  • Communicates installation progress. Keeps the customer, as well as company, up-to-date.
  • Reviews drawings.
  • Is responsible for coordinating, between the customer and Company, any arising installation-related deviations from the contract.
  • Assures that all equipment and systems are installed properly.
  • Concludes an installation project by obtaining Customer Acceptance.
  • Is willing to travel within U.S. & Canada (approx. 90%), with the occasional travel to Mexico, Latin America, Europe; worldwide assignments beyond the aforementioned regions, while rare, are also possible.
  • Is aware of, keeps up-to-date with, and enforces all safety rules & regulations relevant to the job at hand.
  • Manages the Minneapolis Installation Team (mechanical as well as electrical), including the following:
  • Handles job assignments & job scheduling
  • Monitors submitted time sheets and job expenses
  • Evaluates team member’s performance and job skills at the prescribed intervals.
  • Estimates installation time requirements based on a set of conditions.
  • Keeps contacts alive with his/her peers within the global Organization.

Qualifications

  • A.A.S. Manufacturing Engineering Technology or equivalent.
  • 2 years of experience with installations of food/feed processing equipment or grain handling equipment.
  • Has a solid understanding of mechanical installations and how they interface with electrical installations
  • Has a basic understanding of electrical wiring and automation.
  • A minimum of 2 years of experience in installation supervision.
  • Solid leadership skills.
  • Excellent communication skills and relationship-building skills. Can comfortably and effectively work with a variety of people (of different personalities, nationalities, professional backgrounds, etc.)
  • Is able to communicate clearly and effectively in the English language, both verbally and in writing.
  • Must be able to obtain Transportation Worker Identification Credentials (TWIC) and OSHA 10 certification.
  • Mechanical engineering background is a plus.
  • Has the ability to identify, evaluate, and solve problems.
  • Entrepreneurial spirit.
  • Is willing and able to receive training outside of the USA (most likely in Europe), for up to 3 months.



Posted: July 23, 2019, 9:57 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7693
Region : Twin Cities

We are seeking an experienced, high caliber Development Quality Engineer II to assure that new or modified products conform to quality standards and establish compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

Position Responsibilities:

  • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
  • Lead on-time completion of Design Control Deliverables
  • Support on-time execution of Quality Plans for internal product development process (PDP), OEM-based, Clinical Product Development (CPDP), and design change projects
  • Accountable for generation of PDP design verification test plans/reports for product/system requirements
  • Lead or support Risk Management activities from product Concept through Commercialization, including generation of risk management plans/reports, completion and maintenance of hazard analysis, FMECA’s and Cybersecurity risk assessments
  • Lead identification of essential outputs and generate Essential Output reports
  • Accountable for completion of labeling verification activities and labeling verification reports
  • Work with design engineering in the completion of customer/system/product requirements
  • Work with design engineering in the completion of product verification and validation
  • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Complete Document Change Request Reviews in a timely and objective manner
  • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
  • Assist in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
  • Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Additional duties may be identified by functional management based on the current project/business objectives
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

Minimum Requirements:

  • Your experience(s), education and knowledge will further expand marketplace success:
  • Bachelor level degree in Engineering or other Technical Field
  • 2-5 years’ experience
  • Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
  • Working knowledge of FDA 21 CFR Part 820, GMP, and ISO 13485
  • Experience supporting product design and development
  • Solid communication and interpersonal skills
  • Strong verbal communications and written communications with ability to effectively communicate at multiple levels in the Organization
  • Advanced computer skills, including statistical/data analysis and report writing skills
  • Ability to work in a highly matrixed and geographically diverse business environment
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Ability to leverage and/or engage others to accomplish projects
  • Multitasks, prioritizes and meets deadlines in timely manner
  • Strong organizational and follow-up skills, as well as attention to detail
  • Ability to travel approximately 10%, including internationally

Preferred qualifications and education:

  • Prior medical device experience preferred
  • Experience working in a broader enterprise/cross-division business unit model preferred


Posted: July 22, 2019, 10:59 am
Category : Systems Engineer
Job Type : Contract
Id : 7692
Region : Twin Cities

Seeking a Principal Systems Engineer to be responsible for leading a project team of system engineers supporting the need to develop, launch and support a new system.

POSITION RESPONSIBILITIES:

  • Plan (work breakdown structure), schedule, manage system design activities for development projects or programs. Ensure audit readiness of the project/ program. Provide critical feedback to ensure audit readiness and track all review issues identified to closure
  • Collect, analyze, and model design inputs (voice of the customer, voice of the business, etc.) and transform them into high quality stakeholder and system requirements
  • Lead, coordinate, execute, and document system analysis and design activities, including but not limited to security, safety, reliability, risk, usability and interface management
  • Lead cross functional teams—either internal or external—to successfully accomplish short- or long-term design objectives
  • Characterize system performance during development and provide staged integration of system components to assess system maturity
  • Verify that system requirements have been properly implemented (writing, leveling, tracing) through inspection, demonstration, test or analysis
  • Validate that implemented systems meet customer needs through research, analysis, and test evidence
  • Establish and advocate for best practices and continuous improvement as to mature the Systems Engineering knowledge and processes (CoE)
  • Understand and advocate for technology evolution and participate in the development of system and product roadmaps. Be an advocate for high quality engineering.
  • Champion consistent implementation of the Quality System across projects
  • Collect, analyze, and model design inputs requirements and Design Concepts related to system engineering best practices
  • Establish and manage review metrics to enable measurement of the quality of our reviews.

BASIC QUALIFICATIONS:

  • 7+ years of experience with a Bachelor’s Degree; or
  • 5+ years of experience with a Master’s Degree; or
  • 3+ years of experience with a PhD

PREFERRED QUALIFICATIONS:

  • BS in Biomedical Engineering, Systems Engineering, Electrical or Electronic Engineering, Mechanical Engineering, Computer Engineering, Computer Science, or a related field; MS preferred
  • Experience with systems engineering principles, including requirement analysis and allocation, architecture, verification, and validation; INCOSE CSEP a plus
  • Experience with system architecture, analysis, and design, including design partitioning, interface specification, and requirement allocation
  • Experience with highly regulated environments and compliance to standards; experience with successful FDA submissions a plus
  • Strong verbal/written communication skills including presenting and the ability to influence



Posted: July 22, 2019, 10:41 am
Category : Technician - R&D
Job Type : Contract
Id : 7686
Region : Twin Cities

Seeking an R&D Technician for the following duties:

  • Perform experiments and tests on a variety of projects as assigned by engineering.
  • Participate as required within R&D on various engineering efforts for new product development.
  • Assist in the generation of documentation (i.e. drawings, specs, procedures.)
  • MS Word & Excel or SolidWorks
  • Troubleshoot and suggest creative solutions to design and testing issues.
  • Understanding of and ability to utilize electronic data collection systems and computer software packages and possibly ability to analyze data using basic statistics.
  • Ability to prioritize work by determining the sequencing and timing of different jobs based on precedence and importance.
  • Follow safety guidelines and utilize appropriate safety devices when performing all tasks that require such precautions.
  • Create and Maintain accurate records to recreate desired build processes and designs.
  • Willingness for active participation, active listening, interpreting, cooperation and flexibility to allow for a successful self-managed team.
  • Be able to clearly communicate ideas, problems and solutions to engineers.
  • Being a team player is a must for our team.   


Posted: July 12, 2019, 9:52 am
Category : Quality/Regulatory
Job Type : Contract
Id : 7661
Region : Twin Cities

Seeking a Materials Engineer to support product and materials development for new and released medical device products, ensuring product safety and reliability through the direction and execution of characterization testing. This will include providing problem solving, materials laboratory testing and data analysis in support of new and existing implantable biomedical devices and systems. Biocompatibility and biostabiltiy testing, as well as documenting product equivalence through appropriate characterization testing will also be included.

This position will provide materials engineering support to document product compliance with international biocompatibility and hazardous substances standards, supporting regulatory submission. Primary areas of focus include testing for and documenting compliance relating to REACH, RoHS and other regional standards for medical devices. This includes interpretation of standards, interfacing with suppliers for supporting documentation and directing applicable testing to address gaps when necessary.

This person will work under general supervision, solving technical problems  with an emphasis on polymer materials, materials analysis, testing and microscopy.

 

POSITION RESPONSIBILITIES:

  • Guide product development and remediation through the familiarity of international device regulations pertaining to medical devices and Materials of Concern, including RoHS and the European Union Medical Device Directive.
  • Conduct laboratory testing and write technical reports to document device/component compliance with necessary regulations and materials characterization requirements.
  • Work in a regulated environment.
  • Support regulatory submissions with technical rationales/documentation on an as needed basis.
  • Communicate results and strategies via detailed technical documents and presentations.
  • Support the quality and reliability of released product through comparative testing or root cause characterization testing.
  • Participate in the analysis of technical issues and the development of recommendations for project decisions and actions

 

POSITION REQUIREMENTS:

  • Bachelor's degree in materials, chemical, biomedical or mechanical engineering and 5 years experience
  • Materials Science knowledge with an emphasis on polymer materials testing, processing and analysis.
  • Knowledge of international standards, testing and regulatory requirements.
  • Knowledge of Microsoft applications (Excel, Word, Outlook).
  • Experience in a regulated environment.
  • Experience interfacing with suppliers to document regulatory compliance.

 

DESIRED QUALIFICATIONS:

  • Experience in polymer characterization techniques including FTIR, DMA, DSC, TGA and chemical degradation tests.
  • Regional experience in medical devices and regulations such as European Union.
  • Experience developing a medical device, including materials characterization, biocompatibility and biostability.
  • Problem solving skills to identify root cause of materials related issues and ability to recommend mitigation strategies.
  • Experience in regulatory and device regulations for medical devices including biocompatibility and regulated materials.

 

Posted: May 20, 2019, 7:08 am
Category : Mechanical Engineer
Job Type : Contract
Id : 7657
Region : Twin Cities

Looking for a Mechanical Engineer to design medical devices to comply with industry methodologies and standards.  This candidate will define requirements, technologies, and methodologies for individual projects.  Research and analyze data such as experimental data, customer design proposals, specifications, and documentation.  Direct and coordinate actions from product conception through design transfer to ensure products and systems conform to engineering design, standards and customer specifications.  Resolve technical issues and problems.  Effectively communicate their work and status.  Delegate work and leverage engineering technicians and designers.

 

Essential Duties and Responsibilities

  • Applies principles of mechanics, thermodynamics, hydraulics, heat transfer, and materials.
  • Designs medical products and confirms correctness using methodologies and tools such as FEA, GD&T, CFD, etc.
  • Evaluates mechanical and electromechanical systems and products by designing and conducting research programs.
  • Leads and completes medical standard document deliverables.
  • Identifies and efficiently resolves technical problems and issues.
  • Leads and communicates to a client for small scale programs.
  • Researches and analyzes experimental data to understand design issues and set a direction for issue resolution.
  • Prepares product reports by collecting, analyzing, and summarizing information and trends.
  • Delegates and sets work direction for technicians and designers.
  • Works with suppliers and manufacturing facilities to design for manufacturability.

 

Education/Experience:

  • Bachelor's degree in Mechanical Engineering or equivalent
  • Minimum 3+ years of experience in new product development.
  • Direct experience with the product development process ranging from requirements development, prototyping, verification and product release is required.
  • Experience in medical device design or other regulated industries preferred.
  • Must have demonstrated experience working on electromechanical systems.
  • Prefer experience with IEC 60601-1 and with ISO 14971 Risk Management for Medical Devices.
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. 
  • Ability to write reports, business correspondence, and procedure manuals.
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.

 



Posted: May 14, 2019, 11:46 am
Category : Test Engr - Technical
Job Type : Permanent
Id : 7626
Region : Twin Cities

Seeking a Senior Software Test Engineer to provide end to end development of TestStand/LabVIEW solutions for custom functional test systems including, writing requirements; test system development and integration; acceptance testing and technical support.

Major Areas of Accountability:

  • Develop software test system requirements
  • Design software solutions that satisfy test system requirements
  • Lead or participate in design review meetings
  • Collaborate with other engineering disciplines to ensure effective overall system design
  • Provide technical leadership on projects involving multiple engineers, including leading the overall design approach partitioning work among the team and sequencing detailed design activities to support the overall project schedule
  • Support the sales process by providing technical expertise in customer proposals
  • Provides effective communication with project team members, including project status, risks and suggestions to project leadership
  • Collaborate with customers as needed to accomplish customer goals

Education and Experience:

  • Bachelor’s Degree in Electrical Engineering, Computer Science or equivalent experience in a test engineering environment
  • 5 – 10 years of work experience using TestStand and LabVIEW
  • CLD or CLA is preferred
  • Ability to design TestStand or LabVIEW architectures based on system requirements
  • Application software development skills in Microsoft Visual Studio (VB.NET/C#). C/C++ experience a plus
  • Analyze existing test solution (electrical/software) and understand the design for maintenance or updating/upgrading test software
  • Solid analytical skills; able to resolve technical problems with innovative solutions
  • Proven ability to manage working on multiple projects at a time while paying strict attention to detail
  • Proficiency with Microsoft Office Suite
  • Effective verbal and written communication skills
  • Capacity to deal with a high workload and deadline pressure
  • Requires a strong initiative, proactive nature and a sense of urgency
  • Ability to travel 0% - 10% to client locations for meetings and/or system installations
  • Ability to work extended hours as necessary to meet deadlines
  • Must be able to perform in a team environment with good interpersonal skills with commitment to the highest quality achievable
  • Maintains confidentiality and security of intellectual property (ITAR, Prototype)


Posted: April 4, 2019, 12:07 pm
Category : Controls Engineer
Job Type : Permanent
Id : 7556
Region : Twin Cities

Seeking a Systems Engineer to develop control system design and application of various technologies including: multi-axis motion control, image processing, vision-guided robotics, industrial instrumentation & automatic control. This position will provide technical leadership in a team-oriented work environment, interface with customers on technical projects, system programming PLC/motion/vision, startup/commissioning of machine control systems.

Requirements

  • BS or MS in Mechanical or Electrical Engineering with control system emphasis (min 3.2 GPA) and relevant intern or co-op experience.
  • Strong electromechanical aptitude.
  • Motion control/Robotics experience (Delta Tau, Adept, Yamaha, Epson).
  • PLC/PC programming experience (Allen-Bradley, GE Fanuc, etc.).
  • Vision experience (Cognex, DVT, Adept).
  • Solid organizational skills.
  • Strong desire to work in a fast-paced, entrepreneurial environment.
  • Ability to consistently deliver on commitments.


Posted: December 6, 2018, 9:22 am
Category : Software Engineer
Job Type : Contract
Id : 7548
Region : Twin Cities

 

Essential Job Functions & Responsibilities:

  • Embedded firmware design and implementation
  • Support projects for new and existing customers. This will require theoretical analysis, simulation analysis, software/firmware implementation, code review, documentation, and hardware/software integration testing.
  • Support communication protocol development efforts: network security protocols, wireless mesh networking and network security
  • Support development in multiple operating systems:  Linux, FreeRTOS, bare metal, Windows, etc.
  • Coordinate and work collaboratively cross functionally as well as with other software development teams in the organization
  • Lead software efforts being self-directed as well as leading small software teams
  • Mentor junior engineers in current trends and best practices
  • Provide outstanding documentation of software designs
  • Assist with certification testing
  • Coordinate software releases with internal and external stakeholders
  • Participate in appropriate training and development programs to maintain and enhance job-related skills

 

Required Qualifications:

  • Minimum: BS or MS in Computer Engineering, Electrical Engineering or Computer Science
  • 10+ years of related experience
  • Direct experience in programming in C for real-time embedded systems
  • Significant experience working with 32-bit microcontrollers in a flash and RAM constrained system
  • Significant experience with microcontroller peripherals and interfaces: UART, SPI, ADC, PWM, Timers, etc.
  • Development experience with embedded Linux (layers below application) and RTOS/bare metal
  • Skilled in the use of test and debug equipment: oscilloscopes, logic analyzers, multi-meters, spectrum analyzers, etc.
  • Demonstrated ability to function self-directed in leading software engineering efforts
  • Demonstrated ability to lead a small team of software engineers, i.e. task planning/managing, mentoring, defining core architecture, etc.
  • Good communication and team skills, both externally and internally
  • Solid debugging, troubleshooting, and problem solving ability
  • Eagerness to collaborate with team members and coworkers within the organization
  • Solid experience in delivering quality documentation (Requirements, Design Doc's, test plans)
  • Experience working through all phases of software development (Concept, architecture, development, test, release to manufacturing)

 

Preferred Qualifications:

  • Experience in developing Linux Kernel drivers, and low level Linux protocols
  • Experience in developing in real-time operating systems
  • Experience with RF communication
  • Experience with RF protocols at the PHY/MAC/NWK layers such as 802.15.4, zigbee, BLE, or Wi-Fi
  • Experience with networking protocols
  • Experience with a revision control system, GIT is preferred
  • Python experience
  • Experience with unit testing


Posted: November 20, 2018, 11:57 am
Category : Systems Engineer
Job Type : Contract
Id : 7542
Region : Twin Cities

Seeking a Systems Engineer with a strong background and is passionate about system maturity/reliability, integration, characterization, verification, and validation. The ideal candidate would be someone with relevant educational and/or demonstrated experience maturing complex systems with significant electrical and/or software components.

Position Responsibilities:

  • Work with peer systems engineer(s) during development of user needs & intended uses and design input requirements to ensure they are validate-able and verifiable respectively
  • Authors a system level Verification & Validation Plan, documenting scope of system V&V effort, while working with product/functional engineers to ensure proper and complete coverage
  • Authors Integration Plan and corresponding test protocols during design development phase of project to progressively and predictably build design maturity. Executes tests per defined Integration Plan
  • Works with various stakeholders to understand scope of characterization needed, including need to understand design capability. Executes system characterization efforts
  • Influence product/component integration and characterization plans in order to assist in incremental system maturity. Works with engineers in various functional departments to achieve results
  • Authors design verification and design validation protocols and reports. Executes system verification and validation activities
  • Works with Human Factors engineer to ensure inclusion, tracing and proper coverage of applicable user needs in their summative usability study
  • Works with Clinical to ensure inclusion, tracing and proper coverage of applicable intended uses in their pre-clinical or clinical study
  • Plan and execute Test Method and Non-product software validation, and equipment and tooling qualification, per project needs
  • Monitors progress of assigned tasks to defined project schedule
  • Produce high quality deliverables while complying with relevant SOP
  • Authors Summary report and other relevant inputs for submission by Regulatory Affairs to regulatory agencies in support of market release review and approval

Requirements:

  • 4+ years of job-related experience with a Bachelor's degree; or 2+ years of job-related experience with a Master's degree

Preferred Qualifications:

  • Bachelors or Master's Degree in Biomedical Engineering, Systems Engineering, Electrical Engineering, Computer Science, Reliability Engineering, or Mathematics
  • Experience in engineering and testing mission critical systems and/or medical device systems
  • Demonstrated experience maturing System with significant electrical component
  • Experience working with detailed requirements and traceability in order to author test plans, protocols, and reports
  • Experience working in cross-functional team effort
  • Demonstrated strong verbal/written communication and influence management skills
  • Proven ability to accomplish critical project level objectives in a team environment
  • Knowledge of or experience working with Systems Engineering principles
  • Knowledge of or experience working in a regulated and/or FDA medical device environment Knowledge of or experience working with ISO and Quality System Regulation requirements


Posted: November 7, 2018, 8:15 am
Category : Mechanical Designer
Job Type : Contract
Id : 7521
Region : Twin Cities

The Mechanical Designer will be responsible for design of special machines, fixtures, and automated production equipment.

 

Prefer a 2 year degree in mechanical design and 4 to 8+ years of hands on automated equipment design experience, from concept through detailed design.

 

Requirements include strong SolidWorks design skills, and experience in one or more of the following areas: product packaging or assembly equipment, dial and indexing systems, robotics, motion control, for manufacturing equipment. Ability to specify components, drives, material handling systems, pneumatics, and related automation components is required, and experience with medical / pharmaceutical equipment design preferred.



Posted: October 11, 2018, 12:01 pm
Category : Sales
Job Type : Permanent
Id : 7488
Region : Twin Cities

Development Resource Group is a fast-paced, well-established engineering staffing firm seeking a motivated and energetic individual to join our growing recruiting team. Development Resource Group has been supplying contract and direct hire technical staffing since 1986 specializing in Medical Device, Engineering, R&D, and Product Development.

DRG specializes in placement of hardware, software, and mechanical engineering personnel on projects with many high tech product development companies in the Twin Cities. Our engineers are responsible for design, programming, and testing of products for medical device, electronic products, and automation systems.

The Technical Recruiter must have excellent communication skills, a high level of computer system knowledge, and preferably direct experience in sourcing, interviewing, and placement of high-level product development engineers.

We are seeking an individual to manage the full recruiting lifecycle: sourcing, screening, interviewing, reference checking, and negotiating employment terms. The candidate will be well versed in all aspects of professional recruiting, including networking and the recent trends in hiring.

Ideal candidates will be skilled in the use of applicant tracking systems and be self-sufficient in navigating and administering the applicant flow process.

Prefer BS degree, with proven track record of success in the staffing industry.

We offer excellent earning potential, a competitive benefit package, and an opportunity to be successful in the fast-paced, growing technical staffing industry.


 

Posted: September 6, 2018, 9:34 am
Category : Sales
Job Type : Permanent
Id : 7487
Region : Twin Cities

Development Resource Group is a growing Technical Staffing firm located in Mounds View, MN. Since 1986, DRG has been assisting clients in locating experienced engineers for project-based work on a temporary, contract-to-hire, or permanent basis. We specialize in placement of hardware, software, and mechanical engineering personnel with a strong base of high tech product development companies in the Twin Cities. Our engineers are responsible for design, programming, and testing for medical device products, electronic products, control products and automation systems.

We are seeking a motivated and energetic individual to add to our Sales Team as an Account Representative. Account Representatives are responsible for working with our clients in establishing their needs and then working with our recruiting staff to fill those needs. Additionally, they support all contracted staff though the duration of their project, working to ensure both client and contractor's satisfaction. Candidates must have excellent communication skills, a high level of computer systems knowledge, technical staffing experience, be self-motivated and enjoy working in the "people business." A college degree is preferred, with several years of staffing sales experience and/or recruiting experience in a Technical or Engineering field.

We offer an enjoyable working environment with a proven track record in our industry, excellent earning potential, a very competitive benefits package and an opportunity to be successful in the fast-paced, growing technical staffing profession.



Posted: September 6, 2018, 8:20 am
Category : Technician - Medical Equipment
Job Type : Contract
Id : 7319
Region : Twin Cities

Immediate opportunity for an Equipment / Controls Automation Technician to support design, start-up, troubleshooting, and validation of automated equipment for medical device product manufacturing. This position will support Controls Engineers in machine design development, including Autocad Electrical design and documentation of control panels, schematics, and mechanical components, updating / programming PLC and HMI software, support repeat equipment builds, and troubleshooting and solving hardware and software (PLC, HMI, Vision) issues.

Requirements include:

  • 2 year Electrical / Automation Tech degree, with
  • Training and experience in design, programming, and troubleshooting of industrial control systems.
  • Requires proficiency with Autocad Electrical Cad, and training in troubleshooting PLC and HMI systems, robotics, machine vision, and controls instrumentation.
  • Will consider entry level candidate with solid training in automated systems, or technician with up to several years of experience.


Posted: April 2, 2018, 8:52 am
Category : Controls Engineer
Job Type : Contract
Id : 7297
Region : Twin Cities

 

Seeking a Machine Vision Software Engineer / Electrical Engineer / Software Engineer needed to develop and support existing machine vision inspection systems and custom automated control systems used in the development and production of medical devices. Will work within equipment/software engineering group to design machine vision systems, including concept, plans, programming, and troubleshooting for complex manufacturing and test equipment.

 

Requirements:

  • Bachelor of Science (CS or EE)
  • Manager is open to all levels of experience with automated equipment development, including some hands-on vision system knowledge.
  • Prefer experience with .NET and C++ programming, Allen Bradley PLC's and understanding of automated equipment design.
  • Prefer experience with Cognex Vision system development.
  • Exposure to robotic systems a plus.

 

Job Responsibilities:

  • Investigate machine vision software to identify opportunities to increase yields and/or quality of the vision system.
  • Determine root cause with regard to machine vision inspection issues.
  • Update machine vision software for enhancements and bug fixes of existing systems.
  • Investigate machine vision lighting solutions to enhance existing inspection systems.
  • Collect and analyze inspection results to prove robustness of vision system changes.
  • Integrate machine vision system into a PC or PLC based system.
  • Troubleshoot machine vision and controls systems using pneumatic and electrical schematics.
  • Develop/Update departmental standards.
  • Create supporting design documentation.
  • Make software and hardware modifications to existing automated controls equipment.
  • Follow departmental procedures and processes when updating and developing new systems.
  • Participate on project teams to develop clear specifications, evaluate feasibility of concepts, and provide estimates for electrical/software designs.
  • Communicate costs and project status to project lead.
  • Creates electrical/software designs utilizing the departments' standard development tools and procedures.


Posted: March 15, 2018, 12:25 pm
Category : Controls Engineer
Job Type : Contract
Id : 7100
Region : Twin Cities

Excellent opportunity for Controls Automation Engineer to support design and programming of manufacturing / test equipment used in the development and production of medical device products.

 

Requires BS degree (EE, CS) and experience in design and programming of complex industrial machine control systems. This includes PLC / HMI programming, control panel / hardware design, and system troubleshooting and start-up.

 

2-5 years of experience in automated system design, and will consider junior level candidates with control system training and some hands on automation experience.

 

Prefer experience with Allen Bradley/Rockwell Automation PLC and HMI, robotics, motion control, vision systems (Cognex) programming, and system validation and start-up.

 

Prefer experience with SAP and Manufacturing Execution Systems (MES). Experience working within an FDA (or similar) regulated validation and documentation process preferred, and experience with Visual Basic / .NET programming and SQL database development is a plus.



Posted: September 25, 2017, 8:16 am