Manufacturing Engineer-Sr

Planet Pharma; Maple Plain (MN); On-site; USD 37,000 - 51,000; Full time

Job summary

Planet Pharma in Minnesota (Maple Plain) seeks a Manufacturing Engineer to support development, validation, and scale-up of manufacturing processes for a surgical device. You will drive DFMs, tooling, and process improvements while ensuring patient safety and device quality.

The role requires extensive experience in manufacturing or process engineering, working in a regulated medical device environment, and strong cross-functional collaboration with R&D, Quality, and Supply Chain.

Qualifications

• 7-10+ years engineering experience in manufacturing or process engineering, understand manufacturing metrics and continuous improvement tools (e.g., lean, DMAIC)
• Hands-on experience scaling products from prototype to production, fixture/tooling design and implementation
• Strong CAD and problem-solving skills
• Familiarity with regulated medical device environments
• Strong problem-solving skills, attention to detail, self-starter with proven ability to work with minimal supervision, good teamwork and interpersonal skills, good written and verbal communication, ability to multitask, prioritize, and meet project deadlines with high attention to detail
• SolidWorks proficiency desired
• Familiarity with 5s and DMADV

Responsibilities

• Manage special projects and initiatives as assigned, driving them from planning through implementation and final completion
• Lead development and optimization of manufacturing processes for soft-tissue repair device systems
• Drive design for manufacturability (DFM) and transfer of robust processes into high-volume production
• Develop and validate equipment, fixtures, and tooling for assembly and inspection
• Partner cross-functionally with R&D, Quality, and Supply Chain to resolve technical issues and improve output
• Execute structured root-cause analysis and corrective actions for production challenges
• Support process validations, change controls, and documentation in compliance with ISO 13485/FDA QSR

Skills

Manufacturing engineering

Process engineering

Lean / DMAIC

Scale-up from prototype to production

Fixture/tooling design

Strong CAD

Regulated medical devices

Problem solving

Teamwork & communication

SolidWorks

5S / DMADV

Tools

SolidWorks

Job description

Pay Range: 27-37/hr
*depending on exp

Description

This is an exciting opportunity for a well-rounded engineer to join a small team supporting a recently acquired medical device startup. As a Manufacturing Engineer, you will support the development, validation, and scale-up of manufacturing processes for our innovative surgical device — directly contributing to product quality, efficiency, and patient outcomes. In all actions, the Manufacturing Engineer will demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented processes and procedures

• Manage special projects and initiatives as assigned, driving them from planning through implementation and final completion
• Lead development and optimization of manufacturing processes for soft-tissue repair device systems
• Drive design for manufacturability (DFM) and transfer of robust processes into high-volume production
• Develop and validate equipment, fixtures, and tooling for assembly and inspection
• Partner cross-functionally with R&D, Quality, and Supply Chain to resolve technical issues and improve output
• Execute structured root-cause analysis and corrective actions for production challenges
• Support process validations, change controls, and documentation in compliance with ISO 13485/FDA QSR

Skills

• 7-10+ years engineering experience in manufacturing or process engineering, understand manufacturing metrics and continuous improvement tools (e.g., lean, DMAIC)
• Have hands-on experience scaling products from prototype to production is a benefit, skilled in fixture/tooling design and implementation
• Strong CAD and problem-solving skills
• Familiarity with regulated medical device environments
• Strong problem-solving skills, attention to detail, self-starter with proven ability to successfully work with minimal supervision, good teamwork and interpersonal skills, good written and verbal communication, ability to multitask, prioritize, and meet project deadlines with high attention to detail
• SolidWorks proficiency desired
• familiarity with 5s and DMADV

Physical Demands

• Ability to lift up to 30 pounds
• Must be able to wear clean room clothing and work in a cleanroom environment as needed