Manufacturing Engineer II - Medical Devices, High Impact

Minnetronix Medical, Inc.; Minnesota; Ibrido; USD 85.000 - 110.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health, dental, vision

401K plans

Annual bonus program

Descrizione del lavoro

Forj Medical in St Paul, MN is seeking a Manufacturing Engineer II to manage cross-functional production builds across multiple product lines, driving BOM/process control and continuous improvement.

You will work with NPI teams to transfer new products into sustaining production, create and maintain documentation, and ensure quality issues are resolved in collaboration with QA. This role requires FDA ISO knowledge and solid CAD skills.

Competenze

• Bachelor’s degree in an engineering discipline.
• 3–6 years manufacturing engineering experience in electronics-based environment.
• Experience with FDA QSRs and ISO 13485 for medical devices.
• Experience with SolidWorks.
• Ability to write and edit technical documents.
• Strong interpersonal communication and problem-solving skills.
• Proficient with MS Office and data analysis tools.

Mansioni

• Manage the production builds of multiple product lines and issues list.
• Collaborate with NPI to transfer new products into sustaining production.
• Create and maintain production docs: BOMs, procedures, drawings, ECOs.
• Address quality documentation needs with QA and resolve issues.
• Keep production team informed of status and progress.
• Lead continuous improvement for scrap, yield, and labor efficiency.
• Work directly with customers as needed.
• Stay current with medical device requirements and manufacturing trends.

Conoscenze

Interpersonal comms

Analytical skills

Problem solving

Documentation

Teamwork

Independent work

Formazione

Bachelor’s degree in engineering

Strumenti

SolidWorks

MS Office

Descrizione del lavoro

Job Description

Exceptional People. Hard Problems. Meaningful Careers. Big Impact.

Nowhere else can you touch as many life-changing medical technologies. At Forj Medical, we work side by side with more than 100 medical device companies from startups to global giants to bring life-enhancing technologies to market. Working with us means solving hard problems with extraordinary people in a collaborative work environment. Join us.

Job Summary:

At Forj Medical, the Manufacturing Engineer II will work cross functionally to manage the production build of complex electro-mechanical medical devices. A Manufacturing Engineer II is responsible for the production of multiple product lines. Their responsibilities include:issue tracking and resolution, sustaining BOM and process management, continuous improvement (scrap reduction, yield improvement, labor efficiency improvements), and enabling safe and high quality build plan attainment.

Job Duties and Responsibilities:

Manage the production builds of multiple product lines, along with issues list, device improvements and changes. Work withNPIengineering to manage the transfer of new products intosustainingproduction.
• Create and maintain production documentation such as building materials, assembly and test procedures, part drawings, and engineering change orders.
• Address all quality documentation needs for the product line and work with QA to address any quality issues or concerns.
• Keep the production team informed of production status.
• Developed and lead team goals of continuous improvement efforts.
• Work directly with customers as needed.
• Stay current with medical device requirements and maintain technical awareness of new and existing manufacturing processes and trends.

Qualifications and Requirements:

• Bachelor’s degree in an engineering discipline. 3-6 Yrs experience; (MA 2+ yrs).
• 3 to 6 years manufacturing engineering experience in electronic-based manufacturing environment. Medical device preferred, aerospace accepted.
• Experience with regulated environments such as FDA QSR’s, ISO13485 for medical devices and ISO 9001:2000 preferred.
• Experience with SolidWorks
• Ability to write and edit technical documents.
• Strong interpersonal communication.
• Strong analytical skills and problem-solving ability.
• Proficient knowledge of quality improvement tools and techniques.
• Ability to work independently but also function as a team.
• Demonstrated proficiency working with computers and the MS Suite.

Salary: $80,000 - $95,000