Product Engineer II - Primary Talent Partners

Primary Talent Partners has a 12 month contract opening for a Product Engineer II with a large Medical Device client of ours in Boston, MA. 

Hybrid - Onsite 1-3 days a week

Top 3 technical skills that you are required for this role:

• Project Leadership Experience
• Manufacturing Experience with Capital Product
• Experience with Contract Manufacturer

The RPE Engineer will work closely with the project management group, design engineers, and our contract manufacturing sites. You will be able to dive in deep technically, and lead design change initiatives on the capital equipment products used in Robotic Surgery. Also, RPE Engineer could be involved in change investigations and CAPA activities. Outstanding written and verbal communication skills are critical to success in this role, as is the ability to thrive in a fast-paced environment.

Responsibilities:

• Be the key central communications point for sustaining related project activity.
• Track deliverables from internal and external teams against product design change requirements.
• Anticipate, identify, and provide technical solutions to a wide range of difficult problems.
• Mitigate production and manufacturing risks by identifying areas of opportunity and executing improvement projects.
• Assess timeline impacts against project schedule.
• Work with engineers to develop a deep understanding of the technological underpinnings of the system.
• Conducts project management tasks & documentation with design controls and risk analysis in accordance with established SOPs.
• Incorporate required regulatory standards (FDA, ISO) in developmental and/or sustaining engineering projects including written protocols, test methods, assembly processes and the Design History File.
• Prepare reports, presentations and spreadsheets of an analytical and interpretative nature using statistical data analysis methods.

Education:

• Bachelor’s Degree and at least 2 years of relevant engineering experience OR an advanced degree

Nice To Have:

• Ability to create and track a project budget and timeline
• Ability to discuss technical details with engineering staff
• Outstanding verbal and written communication skills
• Strong leadership skills
• Surgical Robotics Experience
• Working knowledge of applicable FDA and ISO standards.
• Working knowledge of Design for Six Sigma, Failure Mode Effects Analysis, Statistical Analysis methods, and Design of Experiments.

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com

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