This position is responsible for contributing to the R&D of breastfeeding products through electrical systems engineering and design verification & validation as part of a team. Interfaces with other development groups and technical support groups. Manages project deliverables into handoff to manufacturing utilizing the Stage Gate process.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Design and analysis of analog, digital and mixed-signal circuits. Project experience may include microcontroller based systems, analog filtering, power circuitry, PCB layout, low-noise amplifiers, impedance matching, timers, isolation circuits, battery/power management.
- Must be comfortable in lab environment creating test circuits, troubleshooting and writing reports.
- Capable of performing circuit simulation and analysis.
- Strong hardware interfacing background and extensive system integration experience with microprocessor hardware and software. Ability to bridge cross functional project needs.
- Experience & working knowledge with at least one scripting language (perl, python, Matlab, etc).
- Demonstrated familiarity & expertise with hardware testing environment and tools. (Oscilloscopes, logic analyzers, programmers)
- Knowledge & application of medical device requirements for European Union, Canadian, Australian, and UL standards
- Knowledge & application of EMC regulations and certification procedures applicable to Medical Devices sold worldwide including testing documentation, certification requirements and procedures (i.e. EN14971, EN60601, CISPR 11, FCC, EU etc.). Ability to perform diagnostics and correct EMC failures.
- Strong experience in Requirements Management, Configuration Management, Defect Tracking and Traceability
- Demonstrated ability to utilize electrical & software design tools and procedures to ensure compliant requirements management and traceability
- Strong team player with ability to meet deadlines and handle changing priorities
- Experience in resolving complex technical problems using strong analytical skills
- Excellent written, oral and interpersonal skills
- Must be proficient at time management and multitasking
- Knowledge of FDA's guidance on design controls and software validation
- Demonstrated experience interfacing with regulatory agencies, conformity assessment bodies (UL, Intertek, CSA, etc.) and standards development organizations (IEC, ISO, NEMA, NFPA, ETSI, etc.) Participate in developing and enhancing Medelas performance relative to the standards.
- Proactively complying with the Stage-Gate process with associated documentation and approvals, achieving targeted product and development costs.
- Responsible for using appropriate project management techniques to ensure the successful completion of assigned projects as lead or as a participant.
- Addressing key project and process issues and risks (define, analyze, resolve).
- Participating effectively as part of the project, and overall Medela team.
- Direct and participate in effective cross-functional interaction between appropriate departments as required by individual assignments.
- Conforms to ISO, FDA, and other regulatory standards, by working with the applicable functional areas as needed.
- All Employees are responsible for learning and complying with all safety and health rules and regulations for their work areas; This includes, but is not limited to: Reporting all incidents and injuries; Supporting the company in providing a safe place to work; Protecting yourself, co-workers and equipment from damage or injury; Cooperating and assisting in incident investigations; Using all appropriate personal protective gear, including seatbelts as required by your job; Practicing sanitary health habits; Following emergency procedures and instructions as needed regarding the specific situation.
This position has no supervisory responsibilities.
Experience and Skills
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Bachelors degree (BS) in Electrical Engineering or related field required.
Minimum 3 years experience in design and implementation of complex embedded software electromechanical systems
Solid track record of accomplishments and engineering success.
Strong systems engineering aptitude
Demonstrated success in difficult decision making and problem resolution
Ability to innovate and create is required.
Medical product or regulated environment experience strongly preferred.
Strong communications and interpersonal skills.
Working knowledge of materials and processes.
Basic business skills.
ENGLISH LANGUAGE SKILLS
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to work and apply related engineering calculations.
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.,) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to sit and talk or hear. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and risk of electrical shock. The noise level in the work environment is usually moderate.
Medela - 23 months ago
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