Medical Device System Engineer

3 weeks ago

Cambridge, United States ACL Digital Full time

Job Title: System Engineer

Location: Cambridge, CA

Duration: 12 Months


Description:

Fully in person Mon - Friday - Preferred that candidates sit in Cambridge, MA but open to candidates in Thousand Oaks, CA.


Ideal Candidate:

Bachelors degree and 2 years of experience required.

• Effective Communicator (Oral/Written)

• Technical Writing (Protocols, Reports, Technical Assessments, Presentations)

• Relevant experience (pharmaceutical industry, combination products, medical devices, etc.)

Nice to haves: Systems engineering background, lab experience.


This position reports into the Systems Engineering group in Cambridge, MA, supporting senior staff in the creation and management of requirements and the development of combination products. This position requires the application of engineering principles to perform the job functions and the ability to coordinate and communicate effectively across different functions to successfully complete projects.


This role will be required to:

• Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution.

• Author and update user need and design requirement documentation using best Systems Engineering principles

• Assist with project definition by performing engineering studies/assessments for drug delivery systems for characterization or qualification in a GMP environment.

• Author and execute protocols and technical reports summarizing key findings and results.

• Design and develop combination product systems.

• Provide detailed data analysis to and recommendations to enable senior staff to make informed decisions.


Preferred/Demonstrated Competencies

• Bachelor’s or Master’s degree in Engineering in mechanical, systems, materials, electrical, or biomedical engineering

• Effective Communicator (Oral/Written)

• Technical Writing (Protocols, Reports, Technical Assessments, Presentations)

• Relevant experience (pharmaceutical industry, combination products, medical devices, etc.)

• INCOSE certification or formal Systems Engineering training/certification

• Lab/testing experience

• Data analysis (software: e.g. JMP, Minitab)

• Project management / multi-tasker to enable managing multiple deliverables/priorities

• Design Controls / Combination Products

• Regulatory Standards

• Problem Solving / Root Cause Analysis

• Strong individual contributor

• Collaborative team player

• Fast and continuous learner

• Flexible/highly adaptive to continuous changing priorities/environment

Basic Qualifications

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Max Rate Not to Exceed (If this differs from the job posting template):

(No Value)

Why is the Position Open?

New position to support an existing workload.

Top 3 Must Have Skill Sets:

• Effective Communicator (Oral/Written)

• Technical Writing (Protocols, Reports, Technical Assessments, Presentations)

• Relevant experience (pharmaceutical industry, combination products, medical devices, etc.)

Nice to haves: Systems engineering background, lab experience.

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