Senior Manufacturing Engineer

RQM+ is
The
MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients — faster, safer, better.

We don't make MedTech. We make MedTech happen.

Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency

In this exciting role as Senior Manufacturing Engineer, you will work with a team to design, develop, fabricate, and qualify new and improved equipment used in the manufacture of life saving devices. These product lines and supporting systems are growing at an accelerated rate and require innovation for greater process efficiency, safety, speed, and quality. The operations group seeks candidates who are intuitive problem solvers and driven to succeed. This role reports to the Manufacturing Engineering Manager.

Responsibilities:

• Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
• Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
• Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
• Adapts machine or equipment design to factory and production conditions.
• May incorporate inspection and test requirements into the production plan.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Ensures processes and procedures are in compliance with regulations.

Requirements:

• Bachelor's degree required with 4+ years of operations and process validation experience, or advanced degree with 2+ years' experience.
• Experience in medical product manufacturing / assembly operations techniques and practices
• Knowledge in Lean Manufacturing / Six Sigma methodologies (A3, DMAIC training)
• Aptitude for quickly learning and simulating a broad array of information
• Experience with line layout, line balancing, and ergonomic analysis
• Excellent data analysis skills, and proficient in the use of statistical tools in problem solving
• Preference to know and understand the whole business

Physical Demands:

• The physical demands described within the Responsibilities section of this job description 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America).

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

Job Opportunity Verification

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All legitimate RQM+ job opportunities are listed on our official careers page:

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