Senior Engineering Manager, Outsourced Manufacturing
scPharmaceuticals’ device manufacturing is outsourced to contract manufacturing organizations (CMOs). The Sr. Engineering Manager of Outsourced Manufacturing is responsible for providing technical review and support for existing medical device products as well as developing new manufacturing capabilities for new products, working out of our Burlington, MA facility. This critical function ensures 100% product availability to meet customer demand by collaborating with our manufacturing partners to develop and implement capacity expansion projects, administer change orders, and guide resolution to manufacturing issues. The Sr. Engineering Manager also helps drive sales growth by developing manufacturing processes for new products, receiving the design transfer from design to manufacturing. The position is full-time, reporting to the Senior Director of Manufacturing.
- Responsible for continued production readiness at our CMO partners to ensure on-going 100% product availability to meet customer demand.
- Understands current capacity constraints, future capacity needs, develops and executes plans to ensure adequate manufacturing capacity to meet customer demand.
- Coordinates with outsourced manufacturing partners to plan and execute required engineering changes, meeting quality, regulatory, and production output requirements.
- Works with the quality department to resolve manufacturing deviations, non-conforming material occurrences, and corrective actions.
- Responsible for overseeing development of manufacturing processes for new products utilizing drug delivery devices.
- Understands new product capacity requirements and ensures new product manufacturing processes will meet anticipated demand.
- Works in conjunction with Product Development, Quality and the CMO partners to develop manufacturing control plans for critical to quality requirements of delivery devices.
- Works in conjunction with Quality and the CMO partners to develop and execute process validation protocols.
- Writes relevant reports and device manufacturing sections of regulatory market approval applications.
- Responsible for driving continuous improvement activities at our CMO partners.
- Sets expectations for CMO performance through the establishment of performance metrics for the quality, cost and delivery of the products.
- Monitors CMO performance through evaluation of performance metrics and develops plans and programs to identify areas of opportunity and drive improvements.
Education, Skills, and Experience:
- BS in Mechanical or Industrial Engineering or related field.
- 7+ years of manufacturing experience, in medical device field, preferably with electro-mechanical assembly and molding.
- Good understanding of Quality Management Systems for Medical Devices and their use to manage suppliers and manufacturing processes.
- Very knowledgeable in Good Manufacturing Practices with specific expertise in process validation and process control.
- Very knowledgeable in Design Control process with specific expertise in Design Transfer and Change Control.
- Proficient in the utilization of document management systems, MasterControl experience is a plus.
- Statistical analysis skill with special emphasis on process capability and ANOVA techniques.
- Project management skills with experience including new product development implementation.
- Working knowledge of commercial contracting and quality agreements, able to manage outsourced operations.
- Proficient in, Excel, Word, Powerpoint, Sharepoint, Visio and MS Project (or Smartsheet).
Abilities and Attributes:
- Highly accountable colleague and leader, following through on commitments.
- Discernment and creativity in establishing relationships with internal colleagues and CMO representatives to promote exceptional teamwork and effective cross-functional collaboration across organizations.
- Excellent communication skills and ability to gain the support and commitment of others for manufacturing initiatives and to collaborate on complex projects.
- Proven ability to identify risks and solve problems related to manufacturing processes.
- Superior planning ability, developing cross-functional project plans that engage functional representatives as appropriate, anticipate risk, and identify task dependencies and critical paths.
- Continuous improvement attitude focused on product and manufacturing performance.
- Courageous in representing the patient and scPharmaceuticals’ needs with our CMO partners.
- Demonstrates self-awareness in turning observations and feedback into productive outcomes and opportunities for improvement.
- Strong work ethic.
- Accountability: You… See it. Own it. Solve it. Do it. You possess a high degree of personal responsibility with a similar expectation of your team and colleagues.
- Commitment to Patients: You have a passion for creating strategic, innovative, valuable, and high-quality solutions and products with a hands-on approach.
- Teamwork: You confer with others to reach resolutions that are acceptable by all parties involved. You can multi-task and productively manage complex situations involving cross functional teams.
- Integrity: You possess and demonstrate a high level of emotional intelligence and professionalism in your decision making. You unfailingly act with integrity and respect for colleagues, business partners and customers in all business dealings.
- Value Driven: You produce consistent, high quality and quantity of outputs and meaningful results that contribute to strategic goals.
- Empowered Communications: You possess and demonstrate strong communication and interpersonal skills.
scPharmaceuticals is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. It is the Company’s policy and intent to provide equal opportunity in employment, development, and advancement without regard to a race, color, religious creed, sex, pregnancy, sexual orientation, gender identity, age, national origin, physical or mental disability, genetic information, ancestry, military service or veteran status, marital status or any other category protected under applicable federal, state or local law.