Cogmedix is a team of talented and caring associates bringing OEM medical technology to life. Providing turnkey manufacturing services to a broad range of medical and dental OEM’s, Cogmedix delivers high quality products to market with compliance, competence, and commitment. Cogmedix provides a high level of flexibility in product launch and demand management and aligns itself with innovative companies that maintain similar high standards in honesty and integrity. Cogmedix is a subsidiary of Coghlin Companies, Inc., a privately held concept to commercialization firm spanning four generations. Visit Cogmedix and sign up for the e-Newsletter at www.Cogmedix.com.
As a member of the engineering services team, the Electrical Engineer I will solve complex problems and participate in the specification, design, prototyping and testing of a diverse range of tooling, fixtures, design for manufacturability projects, and other customer product design needs. Under the direction of the Electrical Engineering Manager, the engineer in this role will be performing design tasks of a complex technical nature requiring investigation of new technologies, and applying engineering design principles and practices.
Position reports to:
Electrical Engineering Manager, Cogmedix
1 Design complex electrical systems for use within, and associated with, medical device systems.
2 Identify and analyze design problems to achieve optimal solutions that satisfy cost and technical requirements using both internal and external technical resources.
3 Research and specify commercial components to meet design requirements.
4 Provide engineering solutions using Best Practices and Policies consistent with company goals and objectives in an open and collaborative manner.
5 Build, troubleshoot, verify and validate engineering prototypes against specifications.
6 Provide engineering services such as work instruction development, tooling and fixture design.
7 Create and refine electrical parts and models to accurately capture design intent.
8 Draft and maintain bill of materials.
9 Prepare and release required design documentation to support release to customer for review including complete engineering change order packages.
10 Support the development of detailed proposals and SOW’s for electrical and software engineering services.
11 Critically review and understand electrical engineering design requirements and specifications as they pertain to a specific project.
12 Contribute to risk assessment of electrical and system design, including generation of FMEAs.
13 Create and communicate project tasks and deliverables, and manage time to meet project deadlines and costs. This includes reporting pertinent information at key milestones through clear, concise oral and written communications with customers and internally.
14 Execute electrical engineering compliant to medical device product safety regulations such as IEC 60601-1 and EMC safety regulations such as IEC 61000-x-x.
15 With guidance, and at all times following the Cogmedix Design Controls compliant process and 21 CFR 820.30, define electrical engineering design requirements and develop specifications in accordance with customer expectations and requirements.
16 Participate in internal and external FDA, ISO 13485, and customer audits as required.
17 Interface and coordinate with senior electrical engineers as well as mechanical and software engineering teams.
18 Maintain positive, high performance environment that fosters extraordinary customer satisfaction and associate retention.
19 Provide support for existing products in production as required.
20 Reinforce and encourage company core values.
21 Performs other duties as required.
1 Positive attitude, self-motivator, and tenacious follow up required.
2 0-5 years of design/development experience.
3 Bachelor’s degree in Electrical Engineering required.
4 Basic working knowledge of electrical design methodologies.
5 Ability to create, design and solve engineering problems with assistance from more senior staff.
6 Demonstrated ability to decompose engineering challenges into actionable task lists.
7 Excellent technical, problem solving and analytical abilities.
8 Excellent skills in MS Office applications.
9 Proficient with OrCAD schematic capture; Altium or PADS PCB layout is a plus.
10 Experienced in both analog and digital circuit design.
11 Proficient in RS232, USB, I2C, SPI, Parallel Bus protocols.
12 Experience with Lasers, FPGA’s, Embedded Control Systems, High Voltage, or Power Supply circuits are a plus.
13 Proficient in at least one programming language; C, C , Visual C , Basic, Visual Basic, or Assembler software languages are a plus.
14 Able to take basic measurements utilizing common test equipment such as a digital multimeter (DMM) and oscilloscope.
15 Demonstrable skill reworking components on a PCBA; IPC J-STD-001 certification a plus.
16 Ability to thrive in a fast paced team setting with engineers, technicians, and manufacturing personnel.
17 Must be flexible, possess strong leadership and interpersonal communication skills as well as the ability to manage multiple priorities.
18 Excellent organizational skills with a commitment to meeting deadlines and expectations while ensuring overall compliance and quality of delivery.
19 Strong decision making capabilities and capacity to handle confidential information.
20 Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources.
21 Excellent negotiation, problem solving, and written and oral communication skills, including experience presenting to customers and internal senior management.
22 A demonstrated commitment to company values.
23 Some experience with ERP/MRP and Data Management systems for documentation revision control preferred. Omnify PLM experience beneficial.
24 Direct experience working in an ISO regulated environment. ISO 13485 preferred.
25 Direct experience working within design controls (21 CFR 820.30) processes required; Experience in phase gate product development is a plus.
Note: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and/or skills required of all personnel so classified.
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