SR MFG & PROCESS DVL ENGINEER

Job Overview

The Sr NPI (New Product Introduction) Engineer leads initiatives to mature medical device products from prototype to market through scaling of assembly processes and influence on device design to ensure DFM. This role collaborates on a global cross functional level with project stakeholders to define a competitive manufacturing strategy, and leads engineers in successful execution. The Sr NPI engineer develops a strong client relationship, mentors colleagues, and is accountable for delivering on COGS, timeline, and budget.

Responsibilities:

• Leads large projects through stage gate process, from small scale prototype production through to high volume commercial manufacturing
• Wide knowledge and experience on engineering technologies to support prototype through high volume manufacture including: fixture design, material handling, bonding technologies, QC methods, application methods, packaging, etc.
• Lead expert of advanced work on multiple assembly technologies (e.g. laser welding, ultrasonic welding, heat staking, sensors, robotics, vision systems, etc.)
• Capable to resource, delegate, constructively critique, and monitor technical work to satisfy packet objectives
• Strong cross-functional global collaboration between PMO, NPD, CR, Quality, BD, and OPS
• Strong external (client facing) communication and presentation skills, where process development objectives and manufacturing strategy are justified through a data driven and risk based approach
• Capable to develop, implement, and qualify potentially complex or advanced assembly processes with a high level of expertise and confidence of DFM
• Capable of identifying risks of inability to meet targeted COGS, and champions solutions to recover
• Bring the technical guidance and mentorship required for the successful execution of challenging milestones and goals within projects
• Ensure the technological and mfg strategy alignment between R&D, PD and Operations
• Generate project work proposals, including evaluation of COGs, timeline, Capex, and NRE estimates
• Planning and implementation of measures to fill technical gaps/risks or failures within the organization
• Mentor NPI Engineers on technical, strategic, quality, and risk identification skillsets, as well as concise internal and external stakeholder communications
• Initiate/manage capital equipment projects; specify and implement new manufacturing equipment.
• Generate test plans, V&V reports, PFMEAs, and Engineering Change Orders
• Utilize statistical process control for product development and manufacturing optimization.
• Maintain collaborative relationships with clients and ensure expected deliverables are met or exceeded within the agreed upon timelines and budget
• Assists EH&S as needed, and champions a safety first process and team culture
• Collaborates with Manufacturing site(s) to proactively plan for and support product transfer
• Leverage lean methodologies, business acumen, and critical thinking to effectively scale and process improve workflows
• Works with team members to motivate and support individual growth
• Obtain components, supplies, and equipment to support prototype assembly, and conduct preliminary OEM vendor assessment and selection
• Champions company vision and culture
• Travel as needed (domestic and international)
• Perform other duties as assigned
  

What your background should look like:

Education

• Bachelor’s Degree in Engineering, Manufacturing or equivalent preferred

Experience

• Designed, Maintained, Scaled, and Improved production lines
• Worked within an ISO 13485 regulated environment
• Minimum of 5 years of experience

Skills

• Strong team player
• Strong understanding of manufacturing transfer
• Manage customer relationships
• Strong problem solving, judgement and decision-making skills
• Strong organizations skills and ability to solve ambiguous situations internal and external to the company
• Proficiency in MS Word, Excel, PowerPoint, and Solidworks
• Excellent communication skills with the ability to speak effectively before groups of Team Members.
• Thrives in a constantly changing business environment.
• Strong leadership skills with the ability to lead cross-functional teams preferred.

Competencies