Core Team Operations Representative (Medtech)

TL;DR

Core Team Operations Representative (Medtech): Leading the operations interface for New Product Development (NPD) with an accent on value stream selection, manufacturing strategy, and implementation of new products. Focus on driving process development, managing project metrics, and ensuring compliance with medical regulations.

Location: Onsite in Lafayette, Colorado, USA

Salary: $138,400 - $207,600

Company

hirify.global is a global healthcare technology leader focused on alleviating pain, restoring health, and extending life through medical innovation.

What you will do

• Act as the primary Operations interface to the New Product Development (NPD) Core team.
• Lead cross-functional extended teams for value stream selection, planning, and execution of new products.
• Develop manufacturing strategies, including site selection, capacity analysis, and capital planning.
• Design manufacturing processes, procedures, and plant layouts to ensure efficient and productive production.
• Manage key project metrics, including predicted product costs and line yields.
• Ensure all manufacturing processes and procedures are in full compliance with industry regulations.

Requirements

• Bachelor's degree with minimum 7 years of engineering experience in manufacturing and/or product development (or Advanced degree with 5 years).
• Unrestricted U.S. work authorization required (sponsorship is not available for this level).
• Experience leading cross-functional teams and driving execution through ambiguously defined situations.
• Proven ability to influence and negotiate requirements to meet program outcomes.

Nice to have

• Advanced degree in an Engineering discipline or an MBA.
• Medical device product development experience and strong understanding of FDA, ICH, and IEC standards.
• DRM, DFSS, or Six Sigma Green Belt certification.
• Experience in highly regulated industries such as pharmaceuticals, avionics, or automotive.
• Experience with manufacturing process validation and problem-solving methodologies.

Culture & Benefits

• Competitive base salary and eligibility for the hirify.global Incentive Plan (MIP).
• Comprehensive health, dental, and vision insurance, including HSA and Healthcare FSA.
• 401(k) plan with employer contribution and matching.
• Paid time off, paid holidays, and an Employee Stock Purchase Plan.
• Tuition assistance/reimbursement and global well-being program (Simple Steps).