Associate Manufacturing Engineer

About the role

The Associate Manufacturing Engineer supports Interventional Urology implantable manufacturing by developing and implementing manufacturing procedures, methods, and processes that will maximize labor, material and equipment utilization while meeting regulatory requirements.

Major Areas of Accountability

• Identify and justify opportunities for implementing equipment upgrades, process improvements, and continuous improvement activities and initiatives.
• Perform equipment, process and product performance qualifications and validations (including risk assessments).
• Perform statistical analysis and report results in a technical protocol/report conforming to FDA standards.
• Conduct root cause analyses and provide resolution of manufacturing issues.
• Manage projects (including capital expenditures) to schedule and within budget.
• Perform all necessary functions from the purchasing, installation, and checkout of new equipment.
• Plan, implement and document designed experiments to support equipment upgrades and process improvements.
• Responsible for GMP compliance of manufacturing equipment/processes.
• Support maintenance activities via utilization of engineering and technical knowledge/skill set.
• Document new and existing procedures as they relate to the manufacturing process.
• Conform with Coloplast Code of Conduct and all local Compliance Standards.
• Conform with Coloplast Q/EHS Policy.
• Other duties as assigned.

Basic Qualifications

• Bachelor’s degree
• 0–2+ years of related manufacturing or relevant work experience
• Self-motivated and self-managed within a dynamic and collaborative team environment
• Strong analytical and problem-solving skills
• High-performing individual that is able to accept challenges and opportunities as they arise

Required Knowledge, Skills and Abilities

• Excellent written & oral communication skills
• Computer skills – Microsoft Office Suite (Access, Word, Excel, PowerPoint)
• Proficient decision-making skills
• Proficient problem-solving and troubleshooting skills
• Ability to effectively interact with various internal and external customers/vendors
• Ability to convey a positive and professional image to internal and external customers
• Ability to exercise sound judgment to resolve manufacturing issues
• Ability to work independently and with team members
• Ability to multitask and prioritize multiple projects
• Ability to work in a fast-paced dynamic environment
• Ability to communicate and train cross-functionally at every level of the business

Environmental Health and Safety Responsibilities

• Seek environmental, health and safety opportunities and make appropriate recommendations
• Comply with corporate standards for environment, health, and safety
• Reduce impacts on environment, health, and safety by systematically optimizing daily operations

Benefits

• Health and Wellness: Comprehensive medical, dental, and vision insurance plans; company-sponsored wellness programs and mental health resources; paid leave of absence for qualifying events; generous paid parental leave for both birthing and non-birthing parents
• Financial Security: Competitive 401(k) plan with company match that vests immediately; financial planning services; corporate discount programs for goods and services
• Work-Life Balance: Generous paid time off; flexible work hours; flexible work arrangement options
• Professional Development: Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement
• Recognition and Rewards: Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events
• Community and Culture: Supportive work environment; team-building activities; volunteer opportunities; company-sponsored events; sustainability strategy

Pay

The compensation range for this position is $70,398 – $105,597. Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location. Hired candidates may be eligible to receive additional compensation in the form of bonuses and/or incentives.